Glycemic Load, Metabolism & Obesity in Pregnancy (PANS)

Dietary Glycemic Load & Metabolism in Obese Pregnant Women

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Insulin Resistance
• Intervention / Treatment: Other: Low Glycemic Load diet; Other: Low Fat Diet

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • San Francisco General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Low Glycemic Load diet; Pregnant women were counseled to consume a diet with a glycemic load per 1000 kcal of less than 55.; Other Names: LGL Diet
Experimental: Low Fat Diet; Pregnant women were counseled to consume a diet providing less that 25% of the energy as fat.	Other: Low Fat Diet; Pregnant women were counseled to consume diets providing less than 25% of the energy as fat.; Other Names: LF Diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
maternal body fat gain	Changes in total body fat as measured by air displacement between 20 to 34 weeks gestation	20-34 weeks gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin Resistance	Changes in insulin resistance measured during an oral glucose tolerance test between 20 to 34 weeks gestation.	20-34 weeks gestation

Collaborators and Investigators

• Sponsor: UCSF Benioff Children's Hospital Oakland
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of California, Davis; University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: January 30, 2011
• First Submitted That Met QC Criteria: January 30, 2011
• First Posted (Estimate): February 1, 2011

Study Record Updates

• Last Update Posted (Actual): November 24, 2020
• Last Update Submitted That Met QC Criteria: November 20, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: obesity; pregnancy; insulin resistance; body composition; gestational weight gain; body fat; diet glycemic load
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Hyperinsulinism; Obesity; Insulin Resistance
• Other Study ID Numbers: 2500-080; R01HD046741 (U.S. NIH Grant/Contract)