PANS: Glycemic Load, Metabolism & Obesity in Pregnancy

Sponsor

UCSF Benioff Children's Hospital Oakland (Other)

Overall Status

Completed

CT.gov ID

NCT01287299

Collaborator

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

Enrollment

Location

Arms

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Insulin Resistance	Other: Low Glycemic Load diet Other: Low Fat Diet	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Dietary Glycemic Load & Metabolism in Obese Pregnant Women

Study Start Date :

Jul 1, 2005

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

maternal body fat gain [20-34 weeks gestation]
Changes in total body fat as measured by air displacement between 20 to 34 weeks gestation

Secondary Outcome Measures

Insulin Resistance [20-34 weeks gestation]
Changes in insulin resistance measured during an oral glucose tolerance test between 20 to 34 weeks gestation.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	San Francisco General Hospital	San Francisco	California	United States	94110

Sponsors and Collaborators

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