NCT03749889

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

September 4, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 21, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2019

Completed
Last Updated

September 18, 2019

Status Verified

September 1, 2019

Enrollment Period

11 months

First QC Date

August 28, 2018

Last Update Submit

September 17, 2019

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

100 g carbs

EXPERIMENTAL

100 grams of carbohydrate allowance for the day

Other: 100 g carbs

MyPlate

ACTIVE COMPARATOR

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

Other: MyPlate

Interventions

100 g carbsOTHER

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

100 g carbs
MyPlateOTHER

40-65% of daily intake is from carbohydrates

MyPlate

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SUNY Buffalo

Buffalo, New York, 14214, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Carbohydrates

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Kai Ling Kong, PhD

    SUNY Buffalo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 28, 2018

First Posted

November 21, 2018

Study Start

September 4, 2018

Primary Completion

August 5, 2019

Study Completion

August 5, 2019

Last Updated

September 18, 2019

Record last verified: 2019-09

Locations

US(1)