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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01846312

Enrollment

Registered

2013-05-03

Start date

2013-05-31

Completion date

2015-09-30

Last updated

2015-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 1

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).

Interventions

OTHERNo treatment given

The participants will not receive any treatment.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

4 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Fluctuation in islet autoantibodies titers	One-two years dependent on sampling frequency

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026