Obesity Clinical Trial
Official title:
Genetics of Beta Cell Failure in Mexican Americans
NCT number | NCT03301519 |
Other study ID # | HS 013025 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2001 |
Est. completion date | May 31, 2013 |
Verified date | November 2023 |
Source | University of Southern California |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1250 |
Est. completion date | May 31, 2013 |
Est. primary completion date | May 31, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years and older |
Eligibility | INCLUSION CRITERIA 1. 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; . 2. Siblings and Cousins of GDM Probands - Full sibling or first cousin of GDM proband - Age >18 yrs - Fasting plasma glucose <126 mg/dl. 3. Parents, Uncles and Aunts of GDM Probands - Full blooded parent, uncle or aunt of GDM proband 4. 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. 5. Spouse of GDM or Control Proband - Spouse of GDM proband - Age >18 - At least one child with proband able to provide DNA 6. Child of Proband - Child of GDM or control proband and spouse who provided DNA EXCLUSION CRITERIA 1. 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. 2. 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. 3. PARENTS OF PROBANDS - Inability or unwillingness to give informed consent. 4. SPOUSE OF GDM or CONTROL PROBAND - Inability or unwillingness to give informed consent. 5. CHILD OF GDM or CONTROL PROBAND - Lack of parent consent or child assent. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Southern California | Kaiser Permanente |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pancreatic Beta Cell Compensation for Insulin Resistance | Disposition index from intravenous glucose tolerance test | Single time point for primary cohort, repeated 4.5 years later in subset | |
Secondary | Insulin Senstivity | Si from computer modeled intravenous glucose tolerance test | Single time point for primary cohort, repeated 4.5 years later in subset | |
Secondary | Acute Insulin Release | 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 | |
Secondary | Glucose tolerance | 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 | |
Secondary | Diabetes type 2 | 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 | |
Secondary | Dietary Intake | Measured by semi-quantitative Harvard Food Frequency Questionnaire | Single time point for primary cohort, repeated 4.5 years later in subset | |
Secondary | Physical Activity | Measured by Multi-ethnic Cohort Physical Activity Questionnaire | Single time point for primary cohort, repeated 4.5 years later in subset | |
Secondary | Body Fat | Percent body fat measured by dual photon X-ray absorptiometry | Single time point for primary cohort, repeated 4.5 years later in subset | |
Secondary | Circulating adipokine levels | Fasting levels of approximately 20 adipocytokines | Single time point for primary cohort, repeated 4.5 years later in subset |
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