Low Carb vs Normal Carb in Pregnancy

Not Applicable

Terminated

• Conditions: Gestational Diabetes
• Interventions: Other: 100 g carbs; Other: MyPlate

• 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

Study Timeline

• Study First Submitted: 2018-08-28
• Study Start: 2018-09-04
• Study First Submitted QC: 2018-11-19
• Study First Posted: 2018-11-21
• Primary Completion: 2019-08-05
• Study Completion: 2019-08-05
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-18

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

Arm && Interventions

Group	Intervention	Description
100 g carbs	100 g carbs	100 grams of carbohydrate allowance for the day
MyPlate	MyPlate	Carbohydrate suggestions based on standard MyPlate. 45-65% kcal intake from carbs.

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.

Trial Locations

Locations (1)

SUNY Buffalo; 🇺🇸 Buffalo, New York, United States