Back to resultsA Pragmatic Approach to Lowering the Risk of Diabetes Mellitus After A Diagnosis of Gestational Diabetes Mellitus
Primary Purpose
Gestational Diabetes
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Metformin
Sponsored by
About this trial
This is an interventional prevention trial for Gestational Diabetes
Eligibility Criteria
Inclusion Criteria:
- Gestational Diabetes
Exclusion Criteria:
- Cannot tolerate metformin
Sites / Locations
- Women & Infants HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Metformin
Routine Care
Arm Description
Metformin 500 mg to be taken twice per day for two weeks and then metformin 1000 mg PO twice daily after tolerating the lower dose
Discharge information about maintaining a healthy diet
Outcomes
Primary Outcome Measures
Prediabetes or Diabetes
glycosylated hemoglobin (HgbA1c) at 1 year postpartum (>/= 5.7% defined as prediabetes, >/=6.5% defined as DM
Secondary Outcome Measures
Prediabetes or diabetes at 15 months postpartum
HgbA1c at 15 months postpartum
Full Information
NCT ID
NCT04615351
First Posted
October 26, 2020
Last Updated
October 31, 2020
Sponsor
Women and Infants Hospital of Rhode Island
1. Study Identification
Unique Protocol Identification Number
NCT04615351
Brief Title
A Pragmatic Approach to Lowering the Risk of Diabetes Mellitus After A Diagnosis of Gestational Diabetes Mellitus
Official Title
A Pragmatic Approach to Lowering the Risk of Diabetes Mellitus After A Diagnosis of Gestational Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 15, 2020 (Anticipated)
Primary Completion Date
October 31, 2021 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Women and Infants Hospital of Rhode Island
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A Pilot of Metformin Postpartum
Detailed Description
The overall goal of this proposal is to assess metformin initiation at the time of hospital discharge for women with a history of gestational diabetes mellitus (GDM) improves maternal health at 1 year post-partum. Our central hypothesis is that diabetes mellitus (DM) prevention with metformin can be initiated days after delivery, rather than months to years after delivery, and result in a pragmatic and efficacious means of preventing DM and improving weight loss over the first year post-partum. To test this hypothesis, we will perform a open-label randomized controlled trial of metformin compared to placebo routine care initiated at the time of hospital discharge in women with a history 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
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Metformin
Arm Type
Active Comparator
Arm Description
Metformin 500 mg to be taken twice per day for two weeks and then metformin 1000 mg PO twice daily after tolerating the lower dose
Arm Title
Routine Care
Arm Type
No Intervention
Arm Description
Discharge information about maintaining a healthy diet
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Medication
Primary Outcome Measure Information:
Title
Prediabetes or Diabetes
Description
glycosylated hemoglobin (HgbA1c) at 1 year postpartum (>/= 5.7% defined as prediabetes, >/=6.5% defined as DM
Time Frame
1 year postpartum
Secondary Outcome Measure Information:
Title
Prediabetes or diabetes at 15 months postpartum
Description
HgbA1c at 15 months postpartum
Time Frame
15 months after delivery and study initiation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Gestational Diabetes
Exclusion Criteria:
Cannot tolerate metformin
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Donna Allard
Phone
4012741122
Email
dallard@wihri.org
Facility Information:
Facility Name
Women & Infants Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erika F Werner, MD
Phone
401-274-1122
Email
ewerner@wihri.org
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
A Pragmatic Approach to Lowering the Risk of Diabetes Mellitus After A Diagnosis of Gestational Diabetes Mellitus
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