Clinical Trials Directory

Trials / Completed

CompletedNCT01287299

Glycemic Load, Metabolism & Obesity in Pregnancy

Dietary Glycemic Load & Metabolism in Obese Pregnant Women

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
64 (actual)
Sponsor
UCSF Benioff Children's Hospital Oakland · Academic / Other
Sex
Female
Age
18 Years – 40 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERLow Glycemic Load dietPregnant women were counseled to consume a diet with a glycemic load per 1000 kcal of less than 55.
OTHERLow Fat DietPregnant women were counseled to consume diets providing less than 25% of the energy as fat.

Timeline

Start date
2005-07-01
Primary completion
2009-12-01
Completion
2009-12-01
First posted
2011-02-01
Last updated
2020-11-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01287299. Inclusion in this directory is not an endorsement.