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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01846312
First received: April 30, 2013
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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 Intervention
Diabetes
Diabetes Mellitus, Type 1
Other: No treatment given

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Fluctuation in islet autoantibodies titers [ Time Frame: One-two years dependent on sampling frequency ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fluctuation in islet autoantibody isotypes [ Time Frame: One-two years dependent on sampling frequency ] [ Designated as safety issue: No ]
  • Fluctuation in T-cell specificity profiling (mainly for CD8 (cluster of differentiation 8) T-cells) [ Time Frame: One-two years dependent on sampling frequency ] [ Designated as safety issue: No ]

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.


Estimated Enrollment: 80
Study Start Date: May 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
All participants Other: No treatment given
The participants will not receive any treatment.

  Eligibility

Ages Eligible for Study:   4 Years to 40 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01846312     History of Changes
Other Study ID Numbers: INS-4074, U1111-1136-8383
Study First Received: April 30, 2013
Last Updated: June 25, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 22, 2014