Genetics of Beta Cell Failure in Mexican Americans

Completed

• Conditions: Gestational Diabetes; Physical Activity; Adipokines; Air Pollution; Genetics; Nutrition; Insulin Resistance; Obesity; Diabetes Type 2; Beta Cell Function

• Registration Number: NCT03301519
• Lead Sponsor: University of Southern California

Brief Summary

This is a family based genotype-phenotype study designed to assess genetic and environmental influences on obesity, insulin resistance and beta cell function in the context of gestational diabetes.

Detailed Description

Mexican American women with prior gestational diabetes and their first degree relatives and Mexican American women with prior normal glucose tolerance in pregnancy are studied with detailed phenotyping consisting of oral and intravenous glucose tolerance tests, body composition studies, diet and physical activity assessments, and circulating biomarkers potentially related to obesity, insulin resistance, pancreatic beta cell function, gestational diabetes and type 2 diabetes. Spouses of the gestational diabetic and control probands are studied with oral glucose tolerance tests. Offspring of the gestational and control probands have fasting glucose determinations. All participants provide DNA for genetics testing. A subset of the gestational diabetic probands and their first degree relatives return 3-5 years after baseline testing for repeat phenotyping.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2001-07-01
• Primary Completion: 2013-05-31
• Study Completion: 2013-05-31
• Study First Submitted: 2017-09-21
• Study First Submitted QC: 2017-09-28
• Study First Posted: 2017-10-04
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1250

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pancreatic Beta Cell Compensation for Insulin Resistance	Single time point for primary cohort, repeated 4.5 years later in subset	Disposition index from intravenous glucose tolerance test

Secondary Outcome Measures

Name	Time	Method
Insulin Senstivity	Single time point for primary cohort, repeated 4.5 years later in subset	Si from computer modeled intravenous glucose tolerance test
Acute Insulin Release	Single time point for primary cohort, repeated 4.5 years later in subset	Incremental area under insulin curve during first 10 minutes intravenous glucose tolerance test
Diabetes type 2	Single time point for primary cohort, repeated 4.5 years later in subset	Fasting glucose \>125 mg/dl and/or 2-hour glucose on 75 gram oral glucose tolerance test \>199 mg/dl
Glucose tolerance	Single time point for primary cohort, repeated 4.5 years later in subset	normal, impaired or diabetic glucose level determined using American Diabetes Associate criteria applied to glucose levels from a 2-hour, 75 gram oral glucose tolerance test
Physical Activity	Single time point for primary cohort, repeated 4.5 years later in subset	Measured by Multi-ethnic Cohort Physical Activity Questionnaire
Body Fat	Single time point for primary cohort, repeated 4.5 years later in subset	Percent body fat measured by dual photon X-ray absorptiometry
Circulating adipokine levels	Single time point for primary cohort, repeated 4.5 years later in subset	Fasting levels of approximately 20 adipocytokines
Dietary Intake	Single time point for primary cohort, repeated 4.5 years later in subset	Measured by semi-quantitative Harvard Food Frequency Questionnaire