Metformin for the Treatment of Microvascular Dysfunction After Gestational Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Metformin Hydrochloride, placebo.
- Who it may be relevant to
- Registry conditions: Gestational Diabetes. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Drug Metformin Hydrochloride
12 weeks: 850mg metformin once daily for first 7 days then twice daily for the remaining 11 weeks. - Other placebo
12 weeks: placebo tablet once daily for the first 7 days then twice daily for the remaining 11 weeks.
Primary outcome measures
- blood flow response to acetylcholine [Time frame: baseline]
- blood flow response to acetylcholine [Time frame: 1 week of treatment]
- blood flow response to acetylcholine [Time frame: 6 weeks of treatment]
- blood flow response to acetylcholine [Time frame: 12 weeks of treatment]
- blood flow response to insulin [Time frame: baseline]
- blood flow response to insulin [Time frame: 1 week of treatment]
- blood flow response to insulin [Time frame: 6 weeks of treatment]
- blood flow response to insulin [Time frame: 12 weeks of treatment]
Secondary outcome measures (4)
- Percentage of nitric oxide-dependent dilation [Time frame: baseline]
- Percentage nitric oxide-dependent dilation [Time frame: 1 week of treatment]
- Percentage of nitric oxide-dependent dilation [Time frame: 6 weeks of treatment]
- Percentage of nitric oxide-dependent dilation [Time frame: 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University of Iowa — Iowa City
Identifiers
NCT: NCT05917587 · 202303345 · 1R01HL169201-01