Status:
COMPLETED
Trial of Diet in Gestational Diabetes Mellitus: Metabolic Consequences to Mother and Offspring
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Gestational Diabetes Mellitus
Eligibility:
All Genders
Up to 36 years
Phase:
NA
Brief Summary
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...
Detailed Description
The rapidly rising incidence of gestational diabetes mellitus in overweight/obese pregnant women demands that an effective diet strategy be developed due to the high risk of fetal overgrowth, which pl...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2020
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT02244814
Start Date
July 1 2015
End Date
November 1 2020
Last Update
December 19 2020
Active Locations (1)
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1
University of Colorado/Anschutz Medical Campus
Aurora, Colorado, United States, 80045