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

NCT01846312 | Completed

• 2 other identifiers: INS-4074U1111-1136-8383
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 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).

Conditions

Diabetes; Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Fluctuation in islet autoantibodies titers

  One-two years dependent on sampling frequency

Secondary Outcomes (2)

• 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

Study Arms (1)

All participants

Other: No treatment given

Interventions

No treatment given OTHER

The participants will not receive any treatment.

All participants

Eligibility Criteria

• Age: 4 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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).

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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Clinical Trial Call Center

Princeton, New Jersey, 08540, United States

Location

Related Links

• Clinical Trials at Novo Nordisk

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.

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2013
• First Posted: May 3, 2013
• Study Start: May 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 23, 2015

Record last verified: 2015-09

Locations

US (1)