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Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM

Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06547619
Enrollment
40
Registered
2024-08-09
Start date
2024-10-01
Completion date
2027-05-01
Last updated
2026-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endothelial Dysfunction, Gestational Diabetes, Physical Inactivity

Brief summary

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 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.

Interventions

DRUGInsulin aspart

insulin aspart is perfused at 5 ascending concentrations (10\^-8M - 10\^-4 M) for 10 minutes each

Sponsors

Anna Stanhewicz, PhD
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
amount of microvascular insulin-mediated dilationat the study visit, an average of 4 hourscutaneous vascular vasodilator responses to insulin perfusion in lactated Ringer's, BQ 788 and BQ-123, and L-NAME treated microdialysis sites

Countries

United States

Contacts

CONTACTAnna Reid-Stanhewicz, PHD
anna-stanhewicz@uiowa.edu319-467-1732

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 30, 2026