- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03301519
Genetics of Beta Cell Failure in Mexican Americans
November 14, 2023 updated by: Thomas Buchanan, University of Southern California
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.
Study Overview
Status
Completed
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.
Study Type
Observational
Enrollment (Actual)
1250
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
See Inclusion and Exclusion Criteria
Description
INCLUSION CRITERIA
Probands with Prior Gestational Diabetes Mellitus ("GDM PROBANDS")
- Mexican American (parents and at least 3/4 four grandparents
- age >18 years
- GDM in singleton pregnancy in prior 5 years
- impaired glucose levels or sum of five OGTT glucose values >625 mg/dl on 75 gram oral glucose tolerance test
- Fasting plasma glucose <126 mg/dl
- At least two adult siblings of cousin not known to have diabetes and available for phenotyping; .
Siblings and Cousins of GDM Probands
- Full sibling or first cousin of GDM proband
- Age >18 yrs
- Fasting plasma glucose <126 mg/dl.
Parents, Uncles and Aunts of GDM Probands
- Full blooded parent, uncle or aunt of GDM proband
Control Proband
- Mexican American as defined for GDM probands
- One glucose challenge test result <120 mg/dl at >24 weeks gestation
- No diabetes in first degree relative
- Frequency matched to GDM probands by distributions of age, BMI and parity.
Spouse of GDM or Control Proband
- Spouse of GDM proband
- Age >18
- At least one child with proband able to provide DNA
Child of Proband
- Child of GDM or control proband and spouse who provided DNA
EXCLUSION CRITERIA
PROBANDS (GDM OR CONTROL):
- Chronic medical illness or medication known to alter glucose/insulin metabolism
- Current pregnancy or breastfeeding
- Ilicit drug or alcohol abuse,
- Inability or unwillingness to give informed consent.
SIBLINGS AND COUSINS OF PROBANDS:
- Chronic medical illness or medication known to affect glucose/insulin metabolism
- Current pregnancy or breastfeeding,
- Ilicit drug or alcohol abuse
- Inability or unwillingness to give informed consent.
PARENTS OF PROBANDS
- Inability or unwillingness to give informed consent.
SPOUSE OF GDM or CONTROL PROBAND
- Inability or unwillingness to give informed consent.
CHILD OF GDM or CONTROL PROBAND
- Lack of parent consent or child assent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pancreatic Beta Cell Compensation for Insulin Resistance
Time Frame: Single time point for primary cohort, repeated 4.5 years later in subset
|
Disposition index from intravenous glucose tolerance test
|
Single time point for primary cohort, repeated 4.5 years later in subset
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insulin Senstivity
Time Frame: Single time point for primary cohort, repeated 4.5 years later in subset
|
Si from computer modeled intravenous glucose tolerance test
|
Single time point for primary cohort, repeated 4.5 years later in subset
|
Acute Insulin Release
Time Frame: 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
|
Single time point for primary cohort, repeated 4.5 years later in subset
|
Glucose tolerance
Time Frame: 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
|
Single time point for primary cohort, repeated 4.5 years later in subset
|
Diabetes type 2
Time Frame: 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
|
Single time point for primary cohort, repeated 4.5 years later in subset
|
Dietary Intake
Time Frame: Single time point for primary cohort, repeated 4.5 years later in subset
|
Measured by semi-quantitative Harvard Food Frequency Questionnaire
|
Single time point for primary cohort, repeated 4.5 years later in subset
|
Physical Activity
Time Frame: Single time point for primary cohort, repeated 4.5 years later in subset
|
Measured by Multi-ethnic Cohort Physical Activity Questionnaire
|
Single time point for primary cohort, repeated 4.5 years later in subset
|
Body Fat
Time Frame: Single time point for primary cohort, repeated 4.5 years later in subset
|
Percent body fat measured by dual photon X-ray absorptiometry
|
Single time point for primary cohort, repeated 4.5 years later in subset
|
Circulating adipokine levels
Time Frame: Single time point for primary cohort, repeated 4.5 years later in subset
|
Fasting levels of approximately 20 adipocytokines
|
Single time point for primary cohort, repeated 4.5 years later in subset
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2001
Primary Completion (Actual)
May 31, 2013
Study Completion (Actual)
May 31, 2013
Study Registration Dates
First Submitted
September 21, 2017
First Submitted That Met QC Criteria
September 28, 2017
First Posted (Actual)
October 4, 2017
Study Record Updates
Last Update Posted (Estimated)
November 16, 2023
Last Update Submitted That Met QC Criteria
November 14, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS 013025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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