Maternal GDM in Hispanic Youth: Risk for Obesity

NCT02668601 | Completed DMC

• 1 other identifier: HS-10-00465
• Study Type: observational
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diabetes, Gestational; Obesity; Insulin Resistance; Insulin Secretion

Keywords

Gestational Diabetes Mellitus; Childhood Obesity; Offspring

Outcome Measures

Primary Outcomes (4)

• Adiposity

  BMI (z-score) and total body fat

  Day 1

• insulin sensitivity

  OGTT

  Day 2

• insulin secretion

  OGTT

  Day 2

• hypothalamic CBF

  fMRI

  Day 3

Study Arms (2)

GDM Exposed

Children exposed to gestational diabetes in utero

Non-GDM Exposed

Children not exposed to gestational diabetes in utero

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

GDM exposed and non-exposed Hispanic offspring of singleton pregnancies between the ages of 4 to 18 years old. Offspring are the children of women with a history of GDM or with normal glucose levels during pregnancy who participated in the BetaGene Study. Normal glucose levels during pregnancy are defined as 1-hour 50g glucose challenge test \<120 mg/dl. GDM diagnosis is defined as two or more abnormal values on 3-h 100-g diagnostic OGTT. GDM defined by American Diabetes Association Criteria in place from 2003-2008.

You may qualify if:

• Offspring between the ages of 4 and 18 years old who were born to women who participated in the BetaGene Study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead

MeSH Terms

Conditions

Diabetes, Gestational; Obesity; Insulin Resistance; Pediatric Obesity

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism

Study Officials

• Kathleen Page, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: January 29, 2016
• Study Start: August 1, 2010
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: April 16, 2019

Record last verified: 2019-04