Investigating the role of NADPH oxidase in blood vessel function after gestational diabetes
Role of NADPH Oxidase in Microvascular Dysfunction Following GDM
This study is testing how a specific enzyme affects blood vessel function in women who had gestational diabetes to see if it helps explain ongoing heart health issues 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 | NCT05946798 on ClinicalTrials.gov |
What this trial studies
This investigation aims to explore how NADPH oxidase contributes to microvascular dysfunction in women with a history of gestational diabetes mellitus (GDM). The study focuses on understanding the mechanisms behind persistent vascular issues that can lead to cardiovascular disease in these women postpartum. Using a minimally invasive technique, researchers will analyze blood vessels in the skin to assess their function and collect endothelial cells for further examination. The study will involve administering acetylcholine and insulin aspart to evaluate their effects on vascular function.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older who have been pregnant within the last five years and have a history of gestational diabetes.
Not a fit: Patients with current skin diseases, metabolic disorders, or those who are currently pregnant may 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 gestational diabetes and cardiovascular risk is established, this specific investigation into NADPH oxidase's role is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
INCLUSION CRITERIA: * 18 years or older * pregnant within 5 years of the study visit * had gestational diabetes diagnosed by their obstetrician and confirmed according to the American College of Obstetricians and Gynecologists criteria for gestational diabetes. * or without a history of 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 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.