Trial of Diet in Gestational Diabetes Mellitus: Metabolic Consequences to Mother and Offspring
Completed · Not applicable
Conditions studied: Gestational Diabetes Mellitus
In brief
The rapidly rising risk of gestational diabetes pregnant women demands that an effective diet strategy be developed due to the high risk of fetal overgrowth, which places the newborn at increased risk for childhood obesity and metabolic syndrome. The aims of this randomized clinical trial are to compare the effects of an 8-wk isocaloric higher complex carbohydrate/lower fat diet vs. a conventional lower carbohydrate (higher fat) diet on glycemic and lipid profiles, maternal insulin resistance, placenta nutrient transporters, the maternal microbiome, neonatal intrahepatic fat, and neonatal total adiposity (primary outcome). The investigators will then follow the infants for 1-yr and measure maternal breast milk and infant microbiome composition to observe if they impact net fat mass gain differently in infants exposed to one diet vs. the other. Identifying a diet for gestational diabetes mellitus women that can effectively alter maternal/fetal metabolism is critical to reducing short- and long-term metabolic risk in this growing cohort of mothers and infants and has the potential to be applicable to overweight/obese pregnant women.
Key facts
- Study ID
- NCT02244814
- Run by
- University of Colorado, Denver
- People needed
- 105
- Starts
- 2015-07-01
- Expected to finish
- 2020-11-01
- Last updated by the study team
- 2020-12-19
Who can join
Age: any, up to 36. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Pregnant women will be between the ages of 20-36 yrs
- BMI of 26-39 kg/m2 at the time of diagnosis
- singleton pregnancy
- no oral hypoglycemic therapy before entering the study
- diagnosed with Gestational diabetes according to the criteria established by the American College of Obstetricians and Gynecologists, specifically, they will have 2 abnormal values on a 100-g 3 hr glucose tolerance test 205, 206: Fasting>95 mg/dL but <105 mg/dL; 1hr> 180 mg/dL; 2 hr>155 mg/dL; 3 hr>140 mg/dL.
You may not qualify if…
- extreme hypertriglyceridemia
- overt diabetes
- suspected preexisting diabetes (A1C≥6.5%, Fasting glucose>125 mg/dL, or random glucose >200/mg/dL)
- women highly likely to fail diet by any of the following criteria will be excluded:1) Fasting glucose >105 mg/dL, due to the higher likelihood of failing diet and requiring medical treatment 139; 2) Fasting triglyceride > 400 mg/dL.
- non-English speaking
- Smokers (leading cause of low birth weight)
- Risk factors for placental insufficiency (hypertension, renal disease, thrombophilias, rheumatologic disease, preeclampsia, steroid use, history of pancreatitis, infectious disease, or intrauterine growth restriction)
- History of pancreatitis
- History of pre-term labor
- Taking beta blockers/glucocorticoids
Where it is running
- University of Colorado/Anschutz Medical Campus — Aurora, Colorado, United States
Full record on ClinicalTrials.gov
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