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

NCT ID: NCT04615351

Last Updated: 2020-11-04

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

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-15

Study Completion Date

2022-06-30

Brief Summary

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A Pilot of Metformin Postpartum

Detailed Description

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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.

Conditions

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Gestational Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Metformin

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

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

Medication

Routine Care

Discharge information about maintaining a healthy diet

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Metformin

Medication

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Gestational Diabetes

Exclusion Criteria

* Cannot tolerate metformin
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Women and Infants Hospital of Rhode Island

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Women & Infants Hospital

Providence, Rhode Island, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Donna Allard

Role: CONTACT

[email protected]
4012741122

Facility Contacts

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Erika F Werner, MD

Role: primary

[email protected]
401-274-1122

Other Identifiers

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1248906-9

Identifier Type: -

Identifier Source: org_study_id