Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM
Key facts
- Who runs it
- Anna Stanhewicz, PhD
- Where
- Iowa City, United StatesSee the site
- Trial code
- Status
- Recruiting
- Phase
- Early phase 1
- People taking part
- 40 people, planned
- Started
- 1 Oct 2024
- Expected to end
- May 2027
- Type of study
- Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Insulin aspart
- Record updated
- 29 October 2026
Who can take part
- Age
- 18 years to 50 years
- Sex
- Women only
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- statin or other cholesterol-lowering medication,
- current antihypertensive medication,
- skin diseases,
- diagnosed or suspected hepatic or metabolic disease including diabetes,
- history of preeclampsia or gestational hypertension
- current hypertension,
- allergy to materials used during the experiment.(e.g. latex), known allergies to study drugs
- current tobacco or electronic cigarette/vape pen use,
- current pregnancy,
- body mass index <18.5 kg/m2,
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 50 years old?
Where in United States
- University of IowaIowa City, United StatesContact: Anna Stanhewicz, PhDTaking people
About the trial
What the trial wants to find out
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.
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The purpose of this investigation is to examine the role of endothelin-1, a potent vasoconstrictor, in aberrant microvascular function in otherwise healthy women with a history of GDM and to identify whether this mechanism is influenced by physical activity and sedentary behavior.
The 4 groups in the trial
- local lactated Ringer's perfusionPlacebo, for comparison
lactated Ringer's is perfused through the microdialysis fiber to serve as the vehicle control
Treatment: Insulin aspart
- local BQ-788 and BQ-123 perfusionTreatment being tested
local ET-1 inhibitors perfused through the microdialysis fiber to serve as the experimental treatment
Treatment: Insulin aspart
- local L-NAME perfusionTreatment being tested
local L-NAME is perfused through the microdialysis fiber to inhibit nitric oxide synthase
Treatment: Insulin aspart
- local BQ-788 + BQ-123 + L-NAME perfusionTreatment being tested
local ET-1 inhibitors and L-NAME are perfused through the microdialysis fiber to inhibit nitric oxide synthase during the experimental treatment
Treatment: Insulin aspart
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Fit questions
- Built from NCT06547619, who can take part
- Record updated
- 29 October 2026