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Glycemic Load, Metabolism & Obesity in Pregnancy (PANS)

This study has been completed.
Sponsor:
Collaborators:
University of California, San Francisco
University of California, Davis
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:
Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier:
NCT01287299
First received: January 30, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Obesity
Insulin Resistance
 Other: Low Glycemic Load diet
Other: Low Fat Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Dietary Glycemic Load & Metabolism in Obese Pregnant Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Hospital & Research Center Oakland:

Primary Outcome Measures:
  • maternal body fat gain [ Time Frame: 20-34 weeks gestation ] [ Designated as safety issue: No ]
    Changes in total body fat as measured by air displacement between 20 to 34 weeks gestation


Secondary Outcome Measures:
  • Insulin Resistance [ Time Frame: 20-34 weeks gestation ] [ Designated as safety issue: No ]
    Changes in insulin resistance measured during an oral glucose tolerance test between 20 to 34 weeks gestation.


Enrollment: 64
Study Start Date: July 2005
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: LF 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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01287299

Locations
United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110
Sponsors and Collaborators
Children's Hospital & Research Center Oakland
University of California, San Francisco
University of California, Davis
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  More Information

No publications provided

Responsible Party: Janet C. King, Children's Hospital Oakland Research Institute
ClinicalTrials.gov Identifier: NCT01287299     History of Changes
Other Study ID Numbers: 2500-080, R01HD046741
Study First Received: January 30, 2011
Last Updated: January 30, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital & Research Center Oakland:
pregnancy
obesity
diet glycemic load
body composition
 body fat
gestational weight gain
insulin resistance

Additional relevant MeSH terms:
Insulin Resistance
Obesity
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
 Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013