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Low Carb vs Normal Carb in Pregnancy

Bump to Baby Study

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03749889
Enrollment
11
Registered
2018-11-21
Start date
2018-09-04
Completion date
2019-08-05
Last updated
2019-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes

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.

Interventions

OTHER100 g carbs

Participants will be assigned a diet of 100g carbs max for the day

OTHERMyPlate

40-65% of daily intake is from carbohydrates

Sponsors

State University of New York at Buffalo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Birth Outcome Questionnaire24 monthsUpon 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026