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Immune Profile in Subjects With New Onset Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT02801942
Recruitment Status : Completed
First Posted : June 16, 2016
Results First Posted : February 27, 2019
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
It is hypothesized that early changes in the immune system in New Onset Type 1 Diabetes Mellitus (NOT1D) subjects can be detected in immune cells from the inguinal lymph nodes (iLN), which will be distinct from changes observed in peripheral blood derived immune cells. Therefore this study will assess and compare the molecular immune profile of cells derived from the iLN in healthy and NOT1D subjects, to understand the immunological processes that may lead to beta cell destruction. It is a multi-center, non-drug treatment study. Up to 15 subjects in each group, namely healthy subjects and NOT1D subjects, will be evaluated in the study. A data look will be carried out after the recruitment of a cohort of up to 5 healthy subjects, to determine if the quality and quantity of cells derived from aspirate or core biopsy or from peripheral blood are likely to be sufficient to continue the study to meet its primary objective. An interim analysis will be carried out after the recruitment of 5 evaluable healthy subjects and 5 evaluable NOT1D subjects. The primary purpose of this interim analysis will be to facilitate decision making and study design for a potential follow-up interventional study.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Procedure: Inguinal lymph node fine needle aspirate biopsy Procedure: Inguinal lymph node core biopsy Procedure: Peripheral blood collection Other: Pre- and post-biopsy questionnaire Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Exploration of the Peripheral Immune System in Subjects With New Onset T1 Diabetes (NOT1D)
Actual Study Start Date : July 25, 2016
Actual Primary Completion Date : December 21, 2017
Actual Study Completion Date : December 21, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Healthy subjects
Up to 30 mL of blood sample will be collected from healthy subjects. Inguinal lymph node fine needle aspirate biopsy and core biopsy will be performed. Leukocyte subset phenotyping will be carried out on iLN-derived cells by assessing expression of (but not restricted to) the following antigens: CD3, CD4, CD8, CD11c, CD14, CD16, CD19, CD24, CD25, CD38, CD45RA, CD56, Human Leukocyte antigen D related (HLA-DR) and forkhead box P3 protein also called scurfin (FOXP3).
Procedure: Inguinal lymph node fine needle aspirate biopsy
Inguinal lymph node will be localized by ultrasonography and sampled by 21-gauge needle and a 5 mL syringe using to and fro needle movement while applying 1 mL suction with the syringe. Up to 2 fine needle aspirate passages will be obtained, to derive immune cells.

Procedure: Inguinal lymph node core biopsy
Inguinal lymph node will be localized by ultrasonography and following fine needle aspirate, an incision will be made. Up to five core biopsies will be obtained, to derive immune cells.

Procedure: Peripheral blood collection
Blood sample (30 mL) will be collected, to derive immune cells.

Other: Pre- and post-biopsy questionnaire
All subjects will be asked to complete a questionnaire about their expectations/experiences of undergoing the biopsy procedures.

Experimental: Subjects with NOT1D
Up to 30 mL of blood sample will be collected from subjects with NOT1D. Inguinal lymph node fine needle aspirate biopsy and core biopsy will be performed. Leukocyte subset phenotyping will be carried out on iLN-derived cells by assessing expression of (but not restricted to) the following antigens: CD3, CD4, CD8, CD11c, CD14, CD16, CD19, CD24, CD25, CD38, CD45RA, CD56, HLA-DR and FOXP3.
Procedure: Inguinal lymph node fine needle aspirate biopsy
Inguinal lymph node will be localized by ultrasonography and sampled by 21-gauge needle and a 5 mL syringe using to and fro needle movement while applying 1 mL suction with the syringe. Up to 2 fine needle aspirate passages will be obtained, to derive immune cells.

Procedure: Inguinal lymph node core biopsy
Inguinal lymph node will be localized by ultrasonography and following fine needle aspirate, an incision will be made. Up to five core biopsies will be obtained, to derive immune cells.

Procedure: Peripheral blood collection
Blood sample (30 mL) will be collected, to derive immune cells.

Other: Pre- and post-biopsy questionnaire
All subjects will be asked to complete a questionnaire about their expectations/experiences of undergoing the biopsy procedures.




Primary Outcome Measures :
  1. Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in Blood [ Time Frame: Pre Biopsy session on Day 1 ]
    Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. The analysis was based upon Safety Population which comprised of all participants who complete any study assessment. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.

  2. Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN [ Time Frame: Biopsy session on Day 1 ]
    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.

  3. Percentage of Leukocyte Subsets Including B-cells, Clusters of Differentiation 56 Positive (CD56+) CD16+ , CD56bright Natural Killer (NK) Cells, CD56lo CD16+, CD56lo CD16 Negative (CD56lo CD16-), Dendritic Cells, NK Cells in Blood [ Time Frame: Pre Biopsy session on Day 1 ]
    Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. NA indicates that data was not available.

  4. Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16-, Dendritic Cells, NK Cells in iLN [ Time Frame: Biopsy session on Day 1 ]
    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.

  5. Percentage of Leukocyte Subsets Including CD56+CD16+, CD56bright NK Cells, CD56lo CD16+ and CD56lo CD16- in Blood [ Time Frame: Pre Biopsy session on Day 1 ]
    Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. NA indicates that data was not available.

  6. Percentage of Leukocyte Subsets Including CD56+CD16+, CD56bright NK Cells CD56lo CD16+ and CD56lo CD16- in iLN [ Time Frame: Biopsy session on Day 1 ]
    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.

  7. Percentage of Leukocyte Subsets Including Myeloid Dendritic Cells and Plasmacytoid Dendritic Cells in Blood [ Time Frame: Pre Biopsy session on Day 1 ]
    Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.

  8. Percentage of Leukocyte Subsets Including Myeloid Dendritic Cells and Plasmacytoid Dendritic Cells in iLN [ Time Frame: Biopsy session on Day 1 ]
    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

  9. Percentage of Leukocyte Subsets Including CD14+ CD16+ Monocytes, CD14+ Monocytes, and CD16+ Monocytes in Blood [ Time Frame: Pre Biopsy session on Day 1 ]
    Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. NA indicates that data was not available.

  10. Percentage of Leukocyte Subsets Including CD14+ CD16+ Monocytes, CD14+ Monocytes and CD16+ Monocytes in iLN [ Time Frame: Biopsy session on Day 1 ]
    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.

  11. Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 Cells in Blood [ Time Frame: Pre Biopsy session on Day 1 ]
    Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.

  12. Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 Cells in iLN [ Time Frame: Biopsy session on Day 1 ]
    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.

  13. Percentage of Leukocyte Subsets Including Programmed Death 1 (PD-1)+ Inducible Costimulator (ICOS)+ Follicular Helper T (TFH) Cell-like Regulatory (Reg) T Cells in Blood [ Time Frame: Pre Biopsy session on Day 1 ]
    Peripheral blood samples were planned to be collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Results could not be presented as data were not collected for this analysis due to lack of model convergence or model reliability

  14. Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cell-like Reg T Cells in iLN [ Time Frame: Biopsy session on Day 1 ]
    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. NA indicates that data was not available.

  15. Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cells in Blood [ Time Frame: Pre Biopsy session on Day 1 ]
    Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.

  16. Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cells in iLN [ Time Frame: Biopsy session on Day 1 ]
    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.

  17. Percentage of Leukocyte Subsets Including Central Memory Conventional (Conv) T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in Blood [ Time Frame: Pre Biopsy session on Day 1 ]
    Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.

  18. Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN [ Time Frame: Biopsy session on Day 1 ]
    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.

  19. Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in Blood [ Time Frame: Pre Biopsy session on Day 1 ]
    Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

  20. Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN [ Time Frame: Biopsy session on Day 1 ]
    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

  21. Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in Blood [ Time Frame: Pre Biopsy session on Day 1 ]
    Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. NA indicates that data was not availble. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

  22. Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN [ Time Frame: Biopsy session on Day 1 ]
    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.

  23. Percentage of Leukocyte Subsets Including Reg T Cells in Blood [ Time Frame: Pre Biopsy session on Day 1 ]
    Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.

  24. Percentage of Leukocyte Subsets Including Reg T Cells in iLN [ Time Frame: Biopsy session on Day 1 ]
    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.

  25. Percentage of Leukocyte Subsets Including CD69+ CD8 and Antigen Ki67 (Ki67)+ CD8 in Blood [ Time Frame: Pre Biopsy session on Day 1 ]
    Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.

  26. Percentage of Leukocyte Subsets Including CD69+ CD8 and Antigen Ki67 (Ki67)+ CD8 in iLN [ Time Frame: Biopsy session on Day 1 ]
    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

  27. Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in Blood [ Time Frame: Pre Biopsy session on Day 1 ]
    Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

  28. Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN [ Time Frame: Biopsy session on Day 1 ]
    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

  29. Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in Blood [ Time Frame: Pre Biopsy session on Day 1 ]
    Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.

  30. Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in iLN [ Time Frame: Biopsy session on Day 1 ]
    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

  31. Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in Blood [ Time Frame: Pre Biopsy session on Day 1 ]
    Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.

  32. Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in iLN [ Time Frame: Biopsy session on Day 1 ]
    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).


Secondary Outcome Measures :
  1. Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN Core Biopsies and iLN FNA [ Time Frame: Biopsy session on Day 1 ]
    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.

  2. Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16, Dendritic Cells, NK Cells in iLN Core Biopsies and iLN FNA [ Time Frame: Biopsy session on Day 1 ]
    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.

  3. Percentage of Leukocyte Subsets Including CD56+CD16+, CD56br NK Cells CD56lo CD16+ and CD56lo CD16- in iLN Core Biopsies and iLN FNA [ Time Frame: Biopsy session on Day 1 ]
    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.

  4. Percentage of Leukocyte Subsets Including Myeloid Dendritic Cells and Plasmacytoid Dendritic Cells in iLN Core Biopsies and iLN FNA [ Time Frame: Biopsy session on Day 1 ]
    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

  5. Percentage of Leukocyte Subsets Including CD14+ CD16+ Monocytes, CD14+ Monocytes and CD16+ Monocytes in iLN Core Biopsies and iLN FNA [ Time Frame: Biopsy session on Day 1 ]
    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates data was not available.

  6. Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 in iLN Core Biopsies and iLN FNA [ Time Frame: Biopsy session on Day 1 ]
    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

  7. Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cell-like Reg T Cells in iLN Core Biopsies and iLN FNA [ Time Frame: Biopsy session on Day 1 ]
    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.

  8. Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cells in iLN Core Biopsies and iLN FNA [ Time Frame: Biopsy session on Day 1 ]
    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

  9. Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN Core Biopsies and iLN FNA [ Time Frame: Biopsy session on Day 1 ]
    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

  10. Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA [ Time Frame: Biopsy session on Day 1 ]
    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

  11. Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA [ Time Frame: Biopsy session on Day 1 ]
    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.

  12. Percentage of Leukocyte Subsets Including Reg T Cells in iLN Core Biopsies and iLN FNA [ Time Frame: Biopsy session on Day 1 ]
    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

  13. Percentage of Leukocyte Subsets Including CD69+ CD8 and Antigen Ki67 (Ki67)+ CD8 in iLN Core Biopsies and iLN FNA [ Time Frame: Biopsy session on Day 1 ]
    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

  14. Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN Core Biopsies and iLN FNA [ Time Frame: Biopsy session on Day 1 ]
    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

  15. Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in iLN Core Biopsies and iLN FNA [ Time Frame: Biopsy session on Day 1 ]
    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

  16. Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in iLN Core Biopsies and iLN FNA [ Time Frame: Biopsy session on Day 1 ]
    Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).

  17. Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs [ Time Frame: Up to Day 14 ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/ birth defect or other situations.

  18. Number of Participants Undergoing Procedure Under Local Anesthetics [ Time Frame: Up to Day 4 ]
    Participants were asked to complete Pre-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The number of participants who underwent procedure under local anesthetics have been presented.

  19. Number of Participants Undergoing iLN Biopsy Under Local Anesthetics [ Time Frame: Up to Day 4 ]
    Participants were asked to complete Pre-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The number of participants who underwent iLN biopsy under local anesthetics have been presented.

  20. Number of Participants With Different Reasons for Participating in the Study [ Time Frame: Up to Day 4 ]
    Participants were asked to complete Pre-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The different reasons have been listed as follows; have friend with diabetes mellitus (DM)/ to progress knowledge, to improve medicines development, participating in the study because of the honorarium, any other reason not listed above was categorized as "other" and participants having all three reasons as listed above to participate in the study were included in "All reasons" category

  21. Number of Participants With Extreme Anxiety Towards the Lymph Node Biopsy [ Time Frame: Up to Day 4 ]
    Participants were asked to complete Pre-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The number of participants with extreme anxiety towards the procedure have been presented.

  22. Number of Participants Looking Forward to Undergo the Procedure [ Time Frame: Up to Day 4 ]
    Participants were asked to complete Pre-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The number of participants looking forward to undergo the procedure have been presented.

  23. Number of Participants With Aspects Better Explained About the Lymph Node Biopsy Procedure [ Time Frame: Up to Day 4 ]
    Participants were asked to complete Post-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The aspects better explained were as follows; itself, anesthetic procedure, after-care, none and any other procedure not listed above was categorized as "other".

  24. Number of Participants Who Considered to Undergo Lymph Node Biopsy Procedure Another Time [ Time Frame: Up to Day 4 ]
    Participants were asked to complete Post-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The number of participants who considered to undergo procedure another time have been presented.

  25. Number of Participants Who Were Encouraged to be Included in Study for iLN Biopsy [ Time Frame: Up to Day 4 ]
    Participants were asked to complete Post-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. Participants who were encouraged in study for iLN biopsy have been presented.

  26. Number of Participants Who Appreciated Receiving Study Feedback [ Time Frame: Up to Day 4 ]
    Participants were asked to complete Post-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. Participants who appreciated receiving study feedback have been presented.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Between 18 and 40 years of age inclusive, at the time of signing the informed consent.
  • Healthy subjects will be as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination and laboratory tests.
  • Subjects will be considered healthy if values for the following parameters: fasted glucose, glycated hemoglobin (HbA1c), International normalized ratio (INR), activated partial thromboplastin time (APTT), platelet count, red blood cells and total lymphocyte count are within the normal range at screening.
  • NOT1D subject with documented diagnosis of diabetes mellitus according to American Diabetes Association (ADA) and World Health Organization (WHO) criteria and consistent with Type 1a (autoimmune) Diabetes Mellitus, with an interval of up to 8 weeks between the initial diagnosis and day 1 of the study (Day 1 = "iLN biopsy" day).
  • NOT1D subject, who currently requires insulin treatment for type 1 diabetes (T1D) and has received insulin therapy for at least 7 days prior to screening.
  • NOT1D subject positive, at screening, for at least one autoantibody associated with T1D: anti- Glutamic Acid Decarboxylase (GAD), anti-Islet antigen 2 (IA-2), anti- islet cell antibodies (ICA), anti-Indole 3 acetic acid (IAA), anti- Zinc transporter 8 (ZnT8).
  • NOT1D subject with evidence, at screening, of residual functioning beta cells as measured by fasted C-peptide levels >=0.15 nanomole per liter (nmol/L).
  • NOT1D subject having values for the following parameters: INR, APTT, platelet count, red blood cells and total lymphocyte count within the normal range at screening.
  • Both, male or female subjects are eligible to participate in this study. A female subject is only eligible to participate if she is not pregnant [as confirmed by a negative urine human chorionic gonadotropin (hCG) test], not lactating at screening and study visit(s) or has documented evidence to not be of child bearing potential.
  • Capable of giving signed informed consent which includes compliance with the study requirements and study restrictions.
  • A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator, in consultation with the Medical Monitor if required, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.

Exclusion Criteria:

  • Healthy subjects having family history of T1D (that is, first degree relative has been diagnosed with T1D)
  • Healthy subjects with presence of one or more of serum autoantibodies, such as anti-GAD, anti-IA2, anti-ICA, anti-IAA, anti-ZnT8, anti-thyroid peroxidase antibodies, anti-tissue transglutaminase antibodies and anti-nuclear antibodies.
  • NOT1D subjects with history of autoimmune disease other than T1D
  • NOT1D subjects with presence of one or more of serum autoantibodies of the following: anti-thyroid peroxidase antibodies, anti-tissue transglutaminase antibodies or anti-nuclear antibodies
  • Allergy or intolerance to local anesthetic agents
  • Any localized groin condition which would contraindicate biopsy procedure including but not limited to: Active infection/inflammation at the intended puncture site, previous surgery/scarring or any other anatomical abnormality as deemed relevant to the procedure by the investigator, in consultation with the Medical Monitor if required.
  • History of bleeding disorders, current or anticipated continuous use of anticoagulant (including but not limited to warfarin, rivaroxaban) and antiplatelet agents (including but not limited to Nonsteroidal anti-inflammatory drugs [NSAIDS], clopidogrel, etc.)
  • Active or unresolved bacterial infection, viral infection, fungal infection within 4 weeks prior to day 1.
  • Known febrile episode over 38 degrees Celsius within 4 weeks prior to day 1.
  • Active organ dysfunction or previous organ allograft.
  • History of malignancy (with the exception of resected basal carcinoma of the skin or cervical carcinoma in situ).
  • Has undergone any major surgical procedure within 30 days before screening, and/or is planning to undergo any such surgery during the period of the study (i.e. from screening until the last follow-up telephone call)
  • Present or previous treatment with any cell depleting therapies or immune-modulating or suppressive agents (e.g., oral steroids), including investigational agents such as the following but not limited to e.g., Interleukin (IL)-2, alemtuzumab, anti- Cluster of Differentiation (CD) 4, anti-CD5, anti-CD3, anti-CD19, anti-CD20.
  • Vaccination =<28 days before day 1 of the study or planned during the study period
  • Current participation in an interventional clinical trial. Subjects, who participated in an interventional clinical trial previously, must wait for 3 months after completing the previous interventional clinical trial before participating in this study.
  • Any medical history or clinically relevant abnormality that is deemed by the investigator and/or medical monitor to make the subject ineligible for inclusion because of a safety concern or any situation that, in the investigator's judgment, is likely to cause the subject to be unable or unwilling to participate in study procedures or to complete all scheduled assessments.
  • A positive pre-study drug/alcohol screen (unless positive due to prescription medication). A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
  • Inability to access the groin area to perform the biopsy procedure as judged by the investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02801942


Locations
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United Kingdom
GSK Investigational Site
Cambridge, United Kingdom, CB2 0QQ
GSK Investigational Site
Cardiff, United Kingdom, CF14 4XN
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
  Study Documents (Full-Text)

Documents provided by GlaxoSmithKline:
Study Protocol  [PDF] March 6, 2017
Statistical Analysis Plan  [PDF] June 9, 2017


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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02801942     History of Changes
Other Study ID Numbers: 203158
First Posted: June 16, 2016    Key Record Dates
Results First Posted: February 27, 2019
Last Update Posted: February 27, 2019
Last Verified: July 2018
Keywords provided by GlaxoSmithKline:
Biomarker
Immune Profile
Biopsy
Leukocyte subsets
Inguinal lymph nodes
Type 1 Diabetes Mellitus
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases