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

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.

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Key information

Conditions

Gestational Diabetes Behavior Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Endothelial Dysfunction Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Physical Inactivity Pregnancy Complications Sedentary Behavior Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

Location status: Recruiting

Location contact

Anna Stanhewicz, PhD

CONTACT

[email protected]

319-467-1732

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

insulin aspart

Drug

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

Primary outcomes

amount of microvascular insulin-mediated dilation

Time frame: at the study visit, an average of 4 hours

cutaneous vascular vasodilator responses to insulin perfusion in lactated Ringer's, BQ 788 and BQ-123, and L-NAME treated microdialysis sites

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Reid-Stanhewicz, PHD

CONTACT

[email protected]

319-467-1732

Sponsors and collaborators

Lead sponsor

Anna Stanhewicz, PhD

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2027
First posted: Aug 9, 2024
Registry last updated: Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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