Glycemic Load, Metabolism & Obesity in Pregnancy

Not Applicable

Completed

• Conditions: Obesity; Insulin Resistance
• Interventions: Other: Low Fat Diet; Other: Low Glycemic Load diet

• Registration Number: NCT01287299
• Lead Sponsor: UCSF Benioff Children's Hospital Oakland

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.

Study Timeline

• Study Start: 2005-07
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2011-01-30
• Study First Submitted QC: 2011-01-30
• Study First Posted: 2011-02-01
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-20
• Last Update Posted: 2020-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Fat Diet	Low Fat Diet	Pregnant women were counseled to consume a diet providing less that 25% of the energy as fat.
Low Glycemic Load Diet	Low Glycemic Load diet	Counseled to consume a diet with a low or higher intake of carbohydrate sources that cause rapid or significant intakes in blood glucose. The average glycemic load of the diet should be less than 55 per 1000 calories or greater than 55 per 1000 calories.

Primary Outcome Measures

Name	Time	Method
maternal body fat gain	20-34 weeks gestation	Changes in total body fat as measured by air displacement between 20 to 34 weeks gestation

Secondary Outcome Measures

Name	Time	Method
Insulin Resistance	20-34 weeks gestation	Changes in insulin resistance measured during an oral glucose tolerance test between 20 to 34 weeks gestation.

Trial Locations

Locations (1)

San Francisco General Hospital; 🇺🇸 San Francisco, California, United States