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OpenTrials
Completed

NCT Number: NCT01287299

Glycemic Load, Metabolism & Obesity in Pregnancy

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.

Completed

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco General Hospital

San Francisco, California, 94110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low Glycemic Load Diet

Other

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

Other names: LGL Diet

Low fat diet

Other

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

Other names: LF Diet

Primary outcomes

  1. maternal body fat gain

    Time frame: 20-34 weeks gestation

    Changes in total body fat as measured by air displacement between 20 to 34 weeks gestation

Secondary outcomes

  1. Insulin Resistance

    Time frame: 20-34 weeks gestation

    Changes in insulin resistance measured during an oral glucose tolerance test between 20 to 34 weeks gestation.

Sponsors and collaborators

Lead sponsor

UCSF Benioff Children's Hospital Oakland

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • University of California, Davis
  • University of California, San Francisco

Registry information

Official study title

Dietary Glycemic Load & Metabolism in Obese Pregnant Women

Acronym: PANS

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Feb 1, 2011
Registry last updated
Nov 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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