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

Completed

Conditions studied: Diabetes, Diabetes Mellitus, Type 1

In brief

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).

Key facts

Study ID

NCT01846312

Run by

Novo Nordisk A/S

People needed

40

Starts

2013-05-01

Expected to finish

2015-09-01

Last updated by the study team

2015-09-23

Who can join

Age: 4 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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))

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Clinical Trial Call Center — Princeton, New Jersey, United States

Full record on ClinicalTrials.gov

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