Metformin for the Treatment of Microvascular Dysfunction After Gestational Diabetes

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

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-11

Study Completion Date

2028-06-30

Brief Summary

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The purpose of this investigation is to examine the mechanisms mediating vascular dysfunction in women who have had gestational diabetes and how metformin may be a valuable treatment tool to improve microvascular function in these women before the onset of disease.

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Detailed Description

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Women with a history of gestational diabetes mellitus (GDM) are at a 2-fold greater risk for the development of overt cardiovascular disease (CVD) following the effected pregnancy. While subsequent development of type II diabetes elevates this risk, prior GDM is an independent risk factor for CVD morbidity, particularly within the first decade postpartum. GDM is associated with impaired endothelial function during pregnancy and decrements in macro- and microvascular function persist postpartum, despite the remission of insulin resistance following delivery. Collectively, while the association between GDM and elevated lifetime CVD risk is clear, and available evidence demonstrates a link between GDM and vascular dysfunction in the decade following pregnancy, the mechanisms mediating this persistent dysfunction remain unexamined.

The purpose of this investigation is to examine the mechanisms mediating vascular dysfunction in women who have had gestational diabetes and how metformin may be a valuable treatment tool to improve microvascular function in these women before the onset of disease. This study will give rise to a new line of research that will center around the goal of improving lifetime cardiovascular outcomes in women with a history of GDM.

In this study, the investigators use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) they examine the blood vessels in a dime-sized area of the skin in women who have had GDM. Local heating of the skin at the microdialysis sites is used to explore differences in mechanisms governing microvascular control. As a compliment to these measurements, the investigators also draw blood from the subjects and isolate the inflammatory cells.

Conditions

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Gestational Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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metformin

Group Type ACTIVE_COMPARATOR

Metformin Hydrochloride

Intervention Type DRUG

12 weeks: 850mg metformin once daily for first 7 days then twice daily for the remaining 11 weeks.

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

12 weeks: placebo tablet once daily for the first 7 days then twice daily for the remaining 11 weeks.

Interventions

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Metformin Hydrochloride

12 weeks: 850mg metformin once daily for first 7 days then twice daily for the remaining 11 weeks.

Intervention Type DRUG

placebo

12 weeks: placebo tablet once daily for the first 7 days then twice daily for the remaining 11 weeks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ≥12 weeks and ≤5 years postpartum
* history of GDM or healthy pregnancy

Exclusion Criteria

* prediabetes or diabetes (HbA1c ≥5.7%)
* current tobacco use
* cardiovascular or metabolic disease
* cardiovascular or metabolic medication
* history of hypertension during pregnancy
* current pregnancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes