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Glycemic Load, Metabolism & Obesity in Pregnancy (PANS)

Primary Purpose

Obesity, Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low Glycemic Load diet
Low Fat Diet
Sponsored by
UCSF Benioff Children's Hospital Oakland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring pregnancy, obesity, diet glycemic load, body composition, body fat, gestational weight gain, insulin resistance

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • San Francisco General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low Glycemic Load Diet

Low Fat Diet

Arm Description

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.

Pregnant women were counseled to consume a diet providing less that 25% of the energy as fat.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 30, 2011
Last Updated
November 20, 2020
Sponsor
UCSF Benioff Children's Hospital Oakland
Collaborators
University of California, San Francisco, University of California, Davis, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT01287299
Brief Title
Glycemic Load, Metabolism & Obesity in Pregnancy
Acronym
PANS
Official Title
Dietary Glycemic Load & Metabolism in Obese Pregnant Women
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCSF Benioff Children's Hospital Oakland
Collaborators
University of California, San Francisco, University of California, Davis, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Insulin Resistance
Keywords
pregnancy, obesity, diet glycemic load, body composition, body fat, gestational weight gain, insulin resistance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Glycemic Load Diet
Arm Type
Experimental
Arm Description
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.
Arm Title
Low Fat Diet
Arm Type
Experimental
Arm Description
Pregnant women were counseled to consume a diet providing less that 25% of the energy as fat.
Intervention Type
Other
Intervention Name(s)
Low Glycemic Load diet
Other Intervention Name(s)
LGL Diet
Intervention Description
Pregnant women were counseled to consume a diet with a glycemic load per 1000 kcal of less than 55.
Intervention Type
Other
Intervention Name(s)
Low Fat Diet
Other Intervention Name(s)
LF Diet
Intervention Description
Pregnant women were counseled to consume diets providing less than 25% of the energy as fat.
Primary Outcome Measure Information:
Title
maternal body fat gain
Description
Changes in total body fat as measured by air displacement between 20 to 34 weeks gestation
Time Frame
20-34 weeks gestation
Secondary Outcome Measure Information:
Title
Insulin Resistance
Description
Changes in insulin resistance measured during an oral glucose tolerance test between 20 to 34 weeks gestation.
Time Frame
20-34 weeks gestation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet C King, Ph.D.
Organizational Affiliation
UCSF Benioff Children's Hospital Oakland
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States

12. IPD Sharing Statement

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Glycemic Load, Metabolism & Obesity in Pregnancy

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