San Francisco General Hospital
San Francisco, California, 94110, United States
NCT Number: NCT01287299
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.
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Notify Me18 year–40 year
Female
Interventional
Not applicable
San Francisco, California, 94110, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pregnant women were counseled to consume a diet with a glycemic load per 1000 kcal of less than 55.
Other names: LGL Diet
Pregnant women were counseled to consume diets providing less than 25% of the energy as fat.
Other names: LF Diet
Time frame: 20-34 weeks gestation
Changes in total body fat as measured by air displacement between 20 to 34 weeks gestation
Time frame: 20-34 weeks gestation
Changes in insulin resistance measured during an oral glucose tolerance test between 20 to 34 weeks gestation.
UCSF Benioff Children's Hospital Oakland
Other
Dietary Glycemic Load & Metabolism in Obese Pregnant Women
Acronym: PANS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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