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

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01846312
• Other study ID #: INS-4074
• Secondary ID: U1111-1136-8383
• Status: Completed
• Phase: N/A
• First received: April 30, 2013
• Last updated: September 22, 2015
• Start date: May 2013
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 40 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Other:
• No treatment given
The participants will not receive any treatment.

Locations

Country	Name	City	State
United States	Novo Nordisk Clinical Trial Call Center	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluctuation in islet autoantibodies titers		One-two years dependent on sampling frequency	No
Secondary	Fluctuation in islet autoantibody isotypes		One-two years dependent on sampling frequency	No
Secondary	Fluctuation in T-cell specificity profiling (mainly for CD8 (cluster of differentiation 8) T-cells)		One-two years dependent on sampling frequency	No

External Links

•   Clinical Trials at Novo Nordisk