Skip to content

Glycemic Load, Metabolism & Obesity in Pregnancy

Dietary Glycemic Load & Metabolism in Obese Pregnant Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01287299
Acronym
PANS
Enrollment
64
Registered
2011-02-01
Start date
2005-07-31
Completion date
2009-12-31
Last updated
2020-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Insulin Resistance

Keywords

pregnancy, obesity, diet glycemic load, body composition, body fat, gestational weight gain, insulin resistance

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.

Interventions

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

OTHERLow Fat Diet

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
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

Design outcomes

Primary

MeasureTime frameDescription
maternal body fat gain20-34 weeks gestationChanges in total body fat as measured by air displacement between 20 to 34 weeks gestation

Secondary

MeasureTime frameDescription
Insulin Resistance20-34 weeks gestationChanges in insulin resistance measured during an oral glucose tolerance test between 20 to 34 weeks gestation.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026