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An Observational Study to Assess Longitudinal Variation of Immune Biomarkers in Subjects at Risk for Development of Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT01846312
Recruitment Status : Completed
First Posted : May 3, 2013
Last Update Posted : September 23, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study is conducted in the United States of America (USA). The aim of the study is to assess longitudinal variation of immune biomarkers in subjects at risk for development of type 1 diabetes (T1D).

Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 1 Other: No treatment given

Study Design

Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Longitudinal Diabetes Biomarker Study: An Observational Study to Assess Longitudinal Variation of Immune Biomarkers in Subjects at Risk for Development of Type 1 Diabetes
Study Start Date : May 2013
Primary Completion Date : September 2015
Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
All participants Other: No treatment given
The participants will not receive any treatment.


Outcome Measures

Primary Outcome Measures :
  1. Fluctuation in islet autoantibodies titers [ Time Frame: One-two years dependent on sampling frequency ]

Secondary Outcome Measures :
  1. Fluctuation in islet autoantibody isotypes [ Time Frame: One-two years dependent on sampling frequency ]
  2. Fluctuation in T-cell specificity profiling (mainly for CD8 (cluster of differentiation 8) T-cells) [ Time Frame: One-two years dependent on sampling frequency ]

Biospecimen Retention:   Samples With DNA
Blood sampling for biomarkers. A portion of each sample collected will be tested for five different islet autoantibodies (presence and precise titers). The remaining portion of each sample will be coded and then assessed for autoantibody isotypes, phenotyping of peripheral blood mononuclear cells (PBMC), and profiling of cytokines, and pharmacogenetic markers.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Subjects who are at risk for developing T1D either by genetic testing or due to family history and identified with one or more islet autoantibodies).
Criteria

Inclusion Criteria:

  • Subjects with general good health as judged by the investigator
  • Participant tested positive at above or equal to 99th percentile for one or more of three islet antibodies (GAD (glutamic acid decarboxylase), IA2 (islet antigen-2), IAA (insulin autoantibody))

Exclusion Criteria:

  • Any chronic disorder (diabetes at enrolment) or severe disease which, in the opinion of the investigator, might jeopardize subject's safety or compliance with the protocol
  • Female of child-bearing potential who is pregnant, breast-feeding, or intends to become pregnant
Contacts and Locations

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): NCT01846312


Locations
United States, New Jersey
Novo Nordisk Clinical Trial Call Center
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01846312     History of Changes
Other Study ID Numbers: INS-4074
U1111-1136-8383 ( Other Identifier: WHO )
First Posted: May 3, 2013    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases