Obesity Clinical Trial
Official title:
Maternal Gestational Diabetes in Hispanic Youth: Obesity and Insulin Resistance
NCT number | NCT02668601 |
Other study ID # | HS-10-00465 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 2010 |
Est. completion date | January 1, 2018 |
Verified date | April 2019 |
Source | University of Southern California |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Our studies are aimed at examining effects of intrauterine exposure to GDM on metabolic risks in Hispanic children. Our primary hypothesis predicts that intrauterine exposure to GDM will be associated with one or more of three critical factors involved in the development of diabetes: 1) increased adiposity, 2) insulin resistance, and 3) decreased beta cell function in Hispanic children when compared to non-exposed children matched for ethnicity, age, gender, and Tanner stage. In a subset of this cohort, we will also examine the effects of intrauterine exposure to gestational diabetes on the brain pathways that regulate appetite and body weight in children ages 6 to 15 years old.
Status | Completed |
Enrollment | 240 |
Est. completion date | January 1, 2018 |
Est. primary completion date | January 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years to 18 Years |
Eligibility |
Inclusion Criteria: - Offspring between the ages of 4 and 18 years old who were born to women who participated in the BetaGene Study. Exclusion Criteria: - Offspring < 4 or > 18 years of age; - gestation < 36 weeks at birth; - significant medical illness and/or current use of medication known to influence glucose tolerance or BMI. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Southern California |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adiposity | BMI (z-score) and total body fat | Day 1 | |
Primary | insulin sensitivity | OGTT | Day 2 | |
Primary | insulin secretion | OGTT | Day 2 | |
Primary | hypothalamic CBF | fMRI | Day 3 |
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