Low Carb vs Normal Carb in Pregnancy

Gestational Diabetes Clinical Trial

Official title:

Bump to Baby Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03749889
• Other study ID #: 00002745
• Status: Terminated
• Phase: N/A
• Start date: September 4, 2018
• Est. completion date: August 5, 2019

Study information

• Verified date: September 2019
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: August 5, 2019
• Est. primary completion date: August 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Intervention

Other:
• 100 g carbs
Participants will be assigned a diet of 100g carbs max for the day
• MyPlate
40-65% of daily intake is from carbohydrates

Locations

Country	Name	City	State
United States	SUNY Buffalo	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Birth Outcome Questionnaire	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.	24 months