Low Carb vs Normal Carb in Pregnancy

September 17, 2019 updated by: Kai Ling Kong, State University of New York at Buffalo

Bump to Baby Study

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14214
        • SUNY Buffalo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 100 g carbs
100 grams of carbohydrate allowance for the day
Other: 100 g carbs
Participants will be assigned a diet of 100g carbs max for the day
Active Comparator: MyPlate
Carbohydrate suggestions based on standard MyPlate. 45-65% kcal intake from carbs.
Other: MyPlate
40-65% of daily intake is from carbohydrates

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Birth Outcome Questionnaire
Time Frame: 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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York at Buffalo

Investigators

  • Principal Investigator: Kai Ling Kong, PhD, SUNY Buffalo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2018

Primary Completion (Actual)

August 5, 2019

Study Completion (Actual)

August 5, 2019

Study Registration Dates

First Submitted

August 28, 2018

First Submitted That Met QC Criteria

November 19, 2018

First Posted (Actual)

November 21, 2018

Study Record Updates

Last Update Posted (Actual)

September 18, 2019

Last Update Submitted That Met QC Criteria

September 17, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00002745

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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