Glycemic Load, Metabolism & Obesity in Pregnancy

NCT ID: NCT01287299

Last Updated: 2020-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2009-12-31

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.

Conditions

Obesity; Insulin Resistance

Keywords

pregnancy; obesity; diet glycemic load; body composition; body fat; gestational weight gain; insulin resistance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Low Glycemic Load diet

Intervention Type: OTHER

Pregnant women were counseled to consume a diet with a glycemic load per 1000 kcal of less than 55.

Low Fat Diet

Pregnant women were counseled to consume a diet providing less that 25% of the energy as fat.

Group Type: EXPERIMENTAL

Low Fat Diet

Intervention Type: OTHER

Pregnant women were counseled to consume diets providing less than 25% of the energy as fat.

Interventions

Low Glycemic Load diet

Pregnant women were counseled to consume a diet with a glycemic load per 1000 kcal of less than 55.

Intervention Type: OTHER

Low Fat Diet

Pregnant women were counseled to consume diets providing less than 25% of the energy as fat.

Intervention Type: OTHER

Other Intervention Names

LGL Diet; LF Diet

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

UCSF Benioff Children's Hospital Oakland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janet C King, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UCSF Benioff Children's Hospital Oakland

Locations

San Francisco General Hospital

San Francisco, California, United States

Countries

United States

Other Identifiers

R01HD046741

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2500-080

Identifier Type: -

Identifier Source: org_study_id