Glycemic Load, Metabolism & Obesity in Pregnancy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Dietary Glycemic Load & Metabolism in Obese Pregnant Women

Conditions
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Obesity, Insulin Resistance

Intervention / Treatment
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* Other: Low Glycemic Load diet
* Other: Low Fat Diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnancy, obesity, diet glycemic load, body composition, body fat, gestational weight gain, insulin resistance