Investigating the role of endothelin-1 in blood vessel function after gestational diabetes
Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM
This study is testing how a substance called endothelin-1 affects blood vessel function in women who had gestational diabetes to see if insulin can help improve their heart health after pregnancy.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | University of Iowa Academic / other |
| Locations | 1 site (Iowa City, Iowa) |
| Trial ID | NCT06547619 on ClinicalTrials.gov |
What this trial studies
This study examines how endothelin-1, a potent vasoconstrictor, affects microvascular function in women who have experienced gestational diabetes mellitus (GDM). It aims to understand the mechanisms behind persistent vascular dysfunction that can occur postpartum, despite the resolution of insulin resistance. The study will involve administering insulin aspart to assess its impact on endothelial function in this population. By focusing on women within five years postpartum, the research seeks to uncover critical insights into cardiovascular risk following GDM.
Who should consider this trial
Good fit: Ideal candidates are women who have had a pregnancy within the last five years, particularly those diagnosed with gestational diabetes.
Not a fit: Patients with current hypertension, metabolic diseases, or those who are currently pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of cardiovascular risks in women with a history of gestational diabetes.
How similar studies have performed: While the association between GDM and cardiovascular risk is established, this specific investigation into endothelin-1's role in microvascular dysfunction is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
INCLUSION CRITERIA * history of pregnancy within 5 years of the study visit * had healthy pregnancy OR had gestational diabetes diagnosed by their obstetrician and confirmed according to the American College of Obstetricians and Gynecologists criteria for gestational diabetes. EXCLUSION CRITERIA * skin diseases, * current tobacco or electronic cigarette/vape pen use, * diagnosed or suspected hepatic or metabolic disease including diabetes, * statin or other cholesterol-lowering medication, * current antihypertensive medication, * history of preeclampsia or gestational hypertension * current hypertension, * current pregnancy, * body mass index \<18.5 kg/m2, * allergy to materials used during the experiment.(e.g. latex), known allergies to study drugs.
Where this trial is running
Iowa City, Iowa
- University of Iowa — Iowa City, Iowa, United States (Recruiting)
Study contacts
- Study coordinator: Anna Reid-Stanhewicz, PHD
- Email: anna-stanhewicz@uiowa.edu
- Phone: 319-467-1732
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.