A Pragmatic Approach to Lowering the Risk of Diabetes Mel... | NCT04615351

Studies
A Pragmatic Approach to Lowering the Risk of Diabetes Mellitus After A Diagnosis of Gestational Diabetes Mellitus

NCT04615351

Sponsor

Women and Infants Hospital of Rhode Island

Status

Unknown status

Last Update Posted

Nov 4, 2020Actual

Enrollment

200Estimated

Phase

Phase 3

Conditions

Gestational Diabetes

Interventions

Metformin

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

Oct 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 15, 2020Estimated

Primary Completion Date

Oct 31, 2021Estimated

Completion Date

Jun 30, 2022Estimated

First Submitted Date

Oct 26, 2020

First Submission Date that Met QC Criteria

Oct 31, 2020

First Posted Date

Nov 4, 2020Actual

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

Oct 31, 2020

Last Update Posted Date

Nov 4, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Metformin	Active Comparator	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	Drug: Metformin
Routine Care	No Intervention	Discharge information about maintaining a healthy diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Metformin	Drug	Medication	Metformin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prediabetes or Diabetes	glycosylated hemoglobin (HgbA1c) at 1 year postpartum (>/= 5.7% defined as prediabetes, >/=6.5% defined as DM	1 year postpartum

Secondary Outcomes

Measure	Description	Time Frame
Prediabetes or diabetes at 15 months postpartum	HgbA1c at 15 months postpartum	15 months after delivery and study initiation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Gestational Diabetes

Exclusion Criteria:

Cannot tolerate metformin

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Donna Allard	Contact	4012741122		dallard@wihri.org

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Women & Infants Hospital	Recruiting	Providence	Rhode Island	02905	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

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
D008687	Metformin

Ancestor Terms

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided