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Low Carb vs Normal Carb in Pregnancy

Primary Purpose

Gestational Diabetes

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
100 g carbs
MyPlate
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gestational Diabetes

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • SUNY Buffalo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

100 g carbs

MyPlate

Arm Description

100 grams of carbohydrate allowance for the day

Carbohydrate suggestions based on standard MyPlate. 45-65% kcal intake from carbs.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 28, 2018
Last Updated
September 17, 2019
Sponsor
State University of New York at Buffalo
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1. Study Identification

Unique Protocol Identification Number
NCT03749889
Brief Title
Low Carb vs Normal Carb in Pregnancy
Official Title
Bump to Baby Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
Unable to provide OBGYN to assist with study for IRB approval
Study Start Date
September 4, 2018 (Actual)
Primary Completion Date
August 5, 2019 (Actual)
Study Completion Date
August 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
100 g carbs
Arm Type
Experimental
Arm Description
100 grams of carbohydrate allowance for the day
Arm Title
MyPlate
Arm Type
Active Comparator
Arm Description
Carbohydrate suggestions based on standard MyPlate. 45-65% kcal intake from carbs.
Intervention Type
Other
Intervention Name(s)
100 g carbs
Intervention Description
Participants will be assigned a diet of 100g carbs max for the day
Intervention Type
Other
Intervention Name(s)
MyPlate
Intervention Description
40-65% of daily intake is from carbohydrates
Primary Outcome Measure Information:
Title
Birth Outcome Questionnaire
Description
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.
Time Frame
24 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kai Ling Kong, PhD
Organizational Affiliation
SUNY Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
SUNY Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Low Carb vs Normal Carb in Pregnancy

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