NCT04187521

Brief Summary

The hypothesis for this study is that women with different physiologic subtypes of gestational diabetes (GDM) (insulin secretion deficit vs. insulin sensitivity deficit) will differ in their glycemic responses to meals with different portions of dietary macronutrients. Investigators will determine GDM subtype based on glucose and insulin levels taken at multiple time points during an oral glucose tolerance test. Participants will consume two meals with different macronutrient content while wearing a continuous glucose monitor which will allow investigators to assess the glycemic response to the meals.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

February 10, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 10, 2022

Status Verified

May 1, 2022

Enrollment Period

2.9 years

First QC Date

December 3, 2019

Last Update Submit

May 7, 2022

Conditions

Gestational Diabetes

Keywords

gestational diabetespregnancydietnutrition

Outcome Measures

Primary Outcomes (1)

  • Peak blood glucose following test meal (CGM)

    Peak postprandial blood glucose after test meal assessed by continuous glucose monitor

    15 mins - 3 hours

Secondary Outcomes (18)

  • One-hour post prandial blood glucose following test meal (SMBG)

    1 hour

  • Glucose area under the curve following test meal (CGM)

    3 hours

  • Meal taste

    1 hour

  • Meal satiety

    3 hours

  • Meal completion

    1 hour

  • +13 more secondary outcomes

Study Arms (3)

Sensitivity defect

OTHER

Participants defined as having abnormal insulin sensitivity without an absolute defect in insulin secretion.

Other: Meal AOther: Meal B

Secretory defect

OTHER

Participants defined as having abnormal insulin secretion without a defect in insulin sensitivity.

Other: Meal AOther: Meal B

Unclassified

OTHER

Participants who cannot be classified as having abnormal insulin secretion or abnormal insulin sensitivity or who have both abnormal insulin sensitivity and abnormal insulin secretion.

Other: Meal AOther: Meal B

Interventions

Meal AOTHER

A breakfast meal with a specific macronutrient proportions.

Secretory defectSensitivity defectUnclassified
Meal BOTHER

A breakfast meal with a specific macronutrient proportions.

Secretory defectSensitivity defectUnclassified

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of gestational diabetes

You may not qualify if:

  • Known diabetes mellitus that preceded pregnancy
  • Food allergies to components of the test meals
  • Use of medications known to affect glucose tolerance
  • Have extensive skin changes or diseases making CGM sensor use problematic
  • Demonstrated allergy to CGM adhesive
  • Inability to adhere to the swimming and bathing instructions
  • Plan to have MRI, CT scan, X Ray or diathermy (heat treatment) during the 7-day CGM study period
  • Inability to adhere to Vitamin C guidelines during study period (using more than 500 mg of Vitamin C/day which could interfere with the CGM)
  • Use of medications known to affect glucose tolerance
  • In the opinion of the principal investigator (PI), demonstrate any other factor likely to limit compliance with the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

RECRUITING

Related Publications (1)

  • Powe CE, Allard C, Battista MC, Doyon M, Bouchard L, Ecker JL, Perron P, Florez JC, Thadhani R, Hivert MF. Heterogeneous Contribution of Insulin Sensitivity and Secretion Defects to Gestational Diabetes Mellitus. Diabetes Care. 2016 Jun;39(6):1052-5. doi: 10.2337/dc15-2672. Epub 2016 May 13.

    PMID: 27208340BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

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

Study Officials

  • Camille E Powe, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manvi Lohia, MPH

CONTACT

617-643-5638hintgdm@partners.org

Emily A Rosenberg, MD

CONTACT

617-643-5638earosenberg@partners.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

December 3, 2019

First Posted

December 5, 2019

Study Start

February 10, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

May 10, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)