Glycemic Load, Metabolism & Obesity in Pregnancy

Obesity Clinical Trial

— PANS  

Official title:

Dietary Glycemic Load & Metabolism in Obese Pregnant Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01287299
• Other study ID #: 2500-080
• Secondary ID: R01HD046741
• Status: Completed
• Phase: N/A
• Start date: July 2005
• Est. completion date: December 2009

Study information

• Verified date: November 2020
• Source: UCSF Benioff Children's Hospital Oakland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity

Intervention

Other:
• Low Glycemic Load diet
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 diets providing less than 25% of the energy as fat.

Locations

Country	Name	City	State
United States	San Francisco General Hospital	San Francisco	California

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Insulin Resistance	Changes in insulin resistance measured during an oral glucose tolerance test between 20 to 34 weeks gestation.	20-34 weeks gestation