Clinical trial NCT01287299: Glycemic Load, Metabolism & Obesity in Pregnancy
Official title: Dietary Glycemic Load & Metabolism in Obese Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Insulin Resistance
Keywords: pregnancy
obesity
diet glycemic load
body composition
body fat
gestational weight gain
insulin resistance
Lead sponsor: UCSF Benioff Children's Hospital Oakland
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: University of California, Davis
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2011-02-01
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to determine if a low glycemic load diet reduces the gain of body fat and insulin resistance during the last half of pregnancy in obese women.

Detailed description: Obese women will be recruited to participate in the study between 14-18 weeks gestation. After determining usual dietary intakes, visceral fat thickness, and the metabolic response to a 100g oral glucose tolerance test (OGTT) at 20 weeks gestation, 45 of the women will be randomly assigned to a low glycemic load (GL) diet and 65 women to a regular low fat diet (current standard care). They will follow their assigned diet for the last 20 weeks of gestation. A dietitian will advise the women and will monitor them throughout the study. At 28 and 34 weeks gestation, the women will come to the General Clinical Research Center (GCRC) at San Francisco General Hospital in the fasting state and the hormonal and metabolic response will be measured to another 100g oral glucose tolerance test (OGTT), and total body fat will be measured. Additional measurements include: 1) longitudinal measurements of maternal visceral fat thickness and fetal size and adiposity at 20 and 34 weeks gestation by ultrasound, 2) collection of cord blood and placental tissue, and 3) measurement of neonatal body composition by dual-energy x-ray absorptiometry and anthropometry at 2-3 weeks of age. Birth outcome data for mother and infant will be collected. To determine the metabolic response to the study diet, 25 women from each of the two diet groups will be assigned to a metabolic subsample for measuring rates of hepatic glucose production and lipolysis at 34 weeks.

Eligibility criteria: Inclusion Criteria:

* \>35% body fat
* 18 to 40 years of age
* speak English or Spanish

Exclusion Criteria:

* have diabetes prior to pregnancy
* diagnosed with GDM in current pregnancy
* smoke
* abuse alcohol or drugs
* have a metabolic disease

Primary outcomes:
measure: maternal body fat gain
timeFrame: 20-34 weeks gestation
Secondary outcomes:
measure: Insulin Resistance
timeFrame: 20-34 weeks gestation
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
Study officials:
affiliation: UCSF Benioff Children's Hospital Oakland
name: Janet C King, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: