Low Carb vs Normal Carb in Pregnancy

NCT ID: NCT03749889

Last Updated: 2019-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-04

Study Completion Date

2019-08-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gestational Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

100 g carbs

100 grams of carbohydrate allowance for the day

Group Type EXPERIMENTAL

100 g carbs

Intervention Type OTHER

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

MyPlate

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

Group Type ACTIVE_COMPARATOR

MyPlate

Intervention Type OTHER

40-65% of daily intake is from carbohydrates

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

100 g carbs

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

Intervention Type OTHER

MyPlate

40-65% of daily intake is from carbohydrates

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

State University of New York at Buffalo

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kai Ling Kong

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kai Ling Kong, PhD

Role: PRINCIPAL_INVESTIGATOR

SUNY Buffalo

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

SUNY Buffalo

Buffalo, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

00002745

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Glycated Albumin in Pregnancy
NCT03372824 COMPLETED