Status:
COMPLETED
Identification of β Cell Dysfunction in Relatives of Individuals With Type 1 Diabetes Mellitus
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Juvenile Diabetes Research Foundation
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
12-55 years
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...
Eligibility Criteria
Inclusion
- Inclusion criteria for each subject group\* note age limits different for each group\*:
- Nonrelative controls: Male and female adults 18-55 years old with no family history of Type 1 Diabetes, who have tested negative for glutamic acid decarboxylase, microinsulin, islet cell, islet antigen 2, and zinc transporter 8 autoantibodies
- Ab negative FDRs: Male and female adults 18-50 years old with a first degree relative (sibling, child, or parent) with T1D, who have tested negative for the above islet autoantibodies
- Ab + T1D Relatives: Male and females aged 12-50 years old with a first or second degree relative diagnosed with T1D, and testing positive for 1 of the above islet autoantibodies either at the screening visit, or through TrialNet screening obtained within the past 12 months.
- Criteria for all subjects:
- BMI≤40 kg/m2 (If FDR is 40 kg/m2, the healthy control BMI can not exceed 45 kg/m2)
- HbA1c\< 5.7%
- No medical history of diabetes.
- Exclusion criteria for all participants:
- Any type of diabetes or hyperglycemia (HbA1c≥5.7%)
- Chronic illness or use of medications which interfere with glucose or islet hormone metabolism.
- Hemoglobin \< 12 g/dL
- Presence of any psychiatric disorder that will affect the ability to participate in the study
- Pregnancy
- Severe milk or soy allergy that would disallow Boost® ingestion for MMTT
- Any condition that, in the judgment of the investigator, will adversely affect adequate participation in, or the safety or technical performance of the protocol.
Exclusion
Key Trial Info
Start Date :
November 14 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 27 2021
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04362917
Start Date
November 14 2017
End Date
August 27 2021
Last Update
March 16 2023
Active Locations (1)
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1
Indiana University
Indianapolis, Indiana, United States, 46202