An observational study in Gestational Diabetes, Diabetes Type 2 and Insulin Resistance, sponsored by University of Southern California. Completed. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by University of Southern California · 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.
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.
877 studies on the registry are indexed under Diabetes, Gestational; 203 are open to participants now.
This study's enrollment of 1,250 is above the median of 180 across 289 observational studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →University of Southern California is the lead sponsor of 791 studies on the registry; 136 are open to participants now.
Of its 70 completed or terminated interventional studies of FDA-regulated products, 32 (46%) have results posted.
Counted across the registry records on this site, refreshed daily.
See Inclusion and Exclusion Criteria
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Probands with Prior Gestational Diabetes Mellitus ("GDM PROBANDS")
Siblings and Cousins of GDM Probands
Parents, Uncles and Aunts of GDM Probands
Control Proband
Spouse of GDM or Control Proband
Child of Proband
EXCLUSION CRITERIA
PROBANDS (GDM OR CONTROL):
SIBLINGS AND COUSINS OF PROBANDS:
PARENTS OF PROBANDS
SPOUSE OF GDM or CONTROL PROBAND
CHILD OF GDM or CONTROL PROBAND
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pancreatic Beta Cell Compensation for Insulin Resistance
Disposition index from intravenous glucose tolerance test
Time frame: Single time point for primary cohort, repeated 4.5 years later in subset
Insulin Senstivity
Si from computer modeled intravenous glucose tolerance test
Time frame: Single time point for primary cohort, repeated 4.5 years later in subset
Acute Insulin Release
Incremental area under insulin curve during first 10 minutes intravenous glucose tolerance test
Time frame: Single time point for primary cohort, repeated 4.5 years later in subset
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
Time frame: Single time point for primary cohort, repeated 4.5 years later in subset
Diabetes type 2
Fasting glucose \>125 mg/dl and/or 2-hour glucose on 75 gram oral glucose tolerance test \>199 mg/dl
Time frame: Single time point for primary cohort, repeated 4.5 years later in subset
Dietary Intake
Measured by semi-quantitative Harvard Food Frequency Questionnaire
Time frame: Single time point for primary cohort, repeated 4.5 years later in subset
Physical Activity
Measured by Multi-ethnic Cohort Physical Activity Questionnaire
Time frame: Single time point for primary cohort, repeated 4.5 years later in subset
Body Fat
Percent body fat measured by dual photon X-ray absorptiometry
Time frame: Single time point for primary cohort, repeated 4.5 years later in subset
Circulating adipokine levels
Fasting levels of approximately 20 adipocytokines
Time frame: Single time point for primary cohort, repeated 4.5 years later in subset
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2001 to primary completion in May 2013, 142 months.
Of 142 non-industry observational studies under Diabetes, Gestational, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 70. This study's 142 months is above that.
Counting every sponsor, half of 144 studies reached it within 43 months; a quarter within 19 and three quarters within 73.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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