Low Carb vs Normal Carb in Pregnancy | NCT03749889

Studies
Low Carb vs Normal Carb in Pregnancy

NCT03749889

Sponsor

State University of New York at Buffalo

Status

Terminated

Last Update Posted

Sep 18, 2019Actual

Enrollment

11Actual

Phase

Not Applicable

Conditions

Gestational Diabetes

Interventions

100 g carbs
MyPlate

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to provide OBGYN to assist with study for IRB approval

Expanded Access Info

Start Date

Sep 4, 2018Actual

Primary Completion Date

Aug 5, 2019Actual

Completion Date

Aug 5, 2019Actual

First Submitted Date

Aug 28, 2018

First Submission Date that Met QC Criteria

Nov 19, 2018

First Posted Date

Nov 21, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2019

Last Update Posted Date

Sep 18, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kai Ling Kong, Principal Investigator, State University of New York at BuffaloPrincipal Investigator

Lead Sponsor

State University of New York at BuffaloOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
100 g carbs	Other	Participants will be assigned a diet of 100g carbs max for the day	100 g carbs

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Female

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kai Ling Kong, PhD	SUNY Buffalo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SUNY Buffalo		Buffalo	New York	14214	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016640	Diabetes, Gestational

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D003920	Diabetes Mellitus

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002241	Carbohydrates

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided