Identification of β Cell Dysfunction in Relatives of Individuals With Type 1 Diabetes Mellitus

Completed

• Conditions: Type 1 Diabetes

• Registration Number: NCT04362917
• Lead Sponsor: Indiana University

Brief Summary

Despite the valuable information derived from older studies evaluating type 1 diabetes, the diabetes research community has, in large part, overlooked potential contributions of baseline abnormalities in β cell function to T1D development. Newer studies focusing on higher risk individuals often exclude family members without evidence of positive islet autoantibodies. New technologies to assay alternative biomarkers of β cell stress and death remain incompletely explored in both Ab negative and Ab positive family members of T1D patients. Specifically, modern biomarkers of β cell dysfunction have not been rigorously tested in combination with metabolic testing to fully understand their association with insulin secretion.

The investigator's working hypothesis is that individuals at genetic risk for T1D exhibit baseline β cell dysfunction, even before development of detectable islet autoimmunity (seropositivity for islet Abs).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-14
• Study First Submitted: 2020-02-19
• Study First Submitted QC: 2020-04-23
• Study First Posted: 2020-04-27
• Primary Completion: 2021-08-27
• Study Completion: 2021-08-27
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-15
• Last Update Posted: 2023-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement of beta cell function during the first phase of the first clamp procedure	The data for this analysis will come from cross-sectional samples collected through study completion, study completion will be on average 13-16 weeks from visit 1.	Our primary outcome is to assess if there is a difference in first phase beta call function in those genetically at risk for developing type 1 diabetes (first degree relatives) but who are islet autoantibody negative versus healthy controls with no family history of type 1 diabetes.; We will calculate the first phase beta cell function by multiplying the acute c-peptide response to glucose (ACPRg) (nmol/L) by the insulin sensitivity (M/I) (x10-5 mmol/kg/min per pmol/L)

Secondary Outcome Measures

Name	Time	Method
Measurement of beta cell function during of Second Phase of the first clamp procedure	The data for this analysis will come from cross-sectional samples collected through study completion, study completion will be on average 13-16 weeks from visit 1.	Our secondary outcome is to assess if there is a difference in second phase beta cell function in those genetically at risk for developing type 1 diabetes (first degree relatives) but who are islet autoantibody negative versus healthy controls with no family history of type 1 diabetes.; We will calculate the second phase beta cell function by averaging the C-peptide values collected during the steady state of the clamp (nmol\*L) and multiplying by the insulin sensitivity (M/I) (x10-5 mmol/kg/min per pmol/L)

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States