An Observational Study to Assess Longitudinal Variation of Immune Biomarkers in Subjects at Risk for Development of Type 1 Diabetes
Completed
- Conditions
- Diabetes Mellitus, Type 1Diabetes
- Registration Number
- NCT01846312
- Lead Sponsor
- Novo Nordisk A/S
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fluctuation in islet autoantibodies titers One-two years dependent on sampling frequency
- Secondary Outcome Measures
Name Time Method Fluctuation in islet autoantibody isotypes One-two years dependent on sampling frequency Fluctuation in T-cell specificity profiling (mainly for CD8 (cluster of differentiation 8) T-cells) One-two years dependent on sampling frequency
Trial Locations
- Locations (1)
Novo Nordisk Clinical Trial Call Center
🇺🇸Princeton, New Jersey, United States
Novo Nordisk Clinical Trial Call Center🇺🇸Princeton, New Jersey, United States