Low Carb vs Normal Carb in Pregnancy
Not Applicable
Terminated
- Conditions
- Gestational Diabetes
- Registration Number
- NCT03749889
- Lead Sponsor
- State University of New York at Buffalo
- Brief Summary
The overall purpose of this intervention study is to examine whether low-carbohydrate dietary intervention will prevent the development of gestational diabetes mellitus (GDM) in high-risk pregnant women. The results of this study should help further our understanding of how pregnant women can help prevent gestational diabetes mellitus. We hypothesize that a lower carbohydrate diet will prevent the development of GDM.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 11
Inclusion Criteria
- 18 - 40 years old
- BMI > 30 and/or history of gestational diabetes mellitus
- Currently in first trimester of pregnancy with single fetus (e.g. not twins, triplets, etc.)
- Newborns of current participants
Exclusion Criteria
- Diabetes (types 1 and 2)
- History of major chronic disease or blood clotting disorders (e.g., cancer, heart disease, kidney disease, hypertension)
- Known fetal anomaly
- History of eating disorders
- Current use of medications that affect appetite or insulin secretion/sensitivity (e.g. stimulants)
- Current use of illegal substances, antipsychotic or opioid substitution medications, alcohol, or tobacco
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Birth Outcome Questionnaire 24 months Upon delivery of the baby, a birth outcome questionnaire will be collected which includes questions about the delivery and birth of the baby and a question about gestational diabetes. The answer to gestational diabetes or not will be the measure for the outcome.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
SUNY Buffalo
🇺🇸Buffalo, New York, United States
SUNY Buffalo🇺🇸Buffalo, New York, United States