Using metformin to improve blood vessel function in women after gestational diabetes
Metformin for the Treatment of Microvascular Dysfunction After Gestational Diabetes
This study is testing if metformin can help improve blood vessel health in women who had gestational diabetes to reduce their risk of heart problems later on.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University of Iowa Academic / other |
| Locations | 1 site (Iowa City, Iowa) |
| Trial ID | NCT05917587 on ClinicalTrials.gov |
What this trial studies
This investigation aims to explore how metformin can enhance microvascular function in women who have experienced gestational diabetes mellitus (GDM). Women with a history of GDM are at an increased risk for cardiovascular disease, and this study seeks to understand the mechanisms behind persistent vascular dysfunction that can occur postpartum. By utilizing a minimally invasive technique to assess blood vessels in the skin, the researchers will evaluate the effectiveness of metformin compared to a placebo in improving vascular health. The findings could pave the way for new strategies to enhance cardiovascular outcomes in this population.
Who should consider this trial
Good fit: Ideal candidates are women who are between 12 weeks and 5 years postpartum and have a history of gestational diabetes.
Not a fit: Patients with prediabetes, diabetes, or existing cardiovascular or metabolic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiovascular health for women with a history of gestational diabetes.
How similar studies have performed: While the association between gestational diabetes and cardiovascular risk is established, this specific approach using metformin for vascular dysfunction is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Iowa City, Iowa
- University of Iowa — Iowa City, Iowa, United States (Recruiting)
Study contacts
- Principal investigator: Anna Stanhewicz, PhD — University of Iowa
- Study coordinator: Anna Stanhewicz, PhD
- Email: anna-stanhewicz@uiowa.edu
- Phone: 3194671732
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.