Clinical trial

Metformin for the Treatment of Microvascular Dysfunction After Gestational Diabetes

Name

202303345

Description

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.

Trial arms

Trial start

2024-06-01

Estimated PCD

2028-07-01

Trial end

2029-07-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

Metformin Hydrochloride

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

Arms:

metformin

placebo

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

Arms:

placebo

Size

Primary endpoint

blood flow response to acetylcholine

baseline

blood flow response to acetylcholine

1 week of treatment

blood flow response to acetylcholine

6 weeks of treatment

blood flow response to acetylcholine

12 weeks of treatment

blood flow response to insulin

baseline

blood flow response to insulin

1 week of treatment

blood flow response to insulin

6 weeks of treatment

blood flow response to insulin

12 weeks of treatment

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

Updated at

2024-04-17

1 organization

1 drug

1 indication

Organization

Anna Stanhewicz

Drug

Metformin

Indication

Gestational Diabetes