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

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Anna Stanhewicz, PhD
Study ID
NCT06547619
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Endothelial Dysfunction
  • Gestational Diabetes
  • Physical Inactivity

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 1, 2024
Status verified
Dec 2025
Primary completion
May 31, 2026
Completion
May 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Placebo Comparator: local lactated Ringer's perfusion
    lactated Ringer's is perfused through the microdialysis fiber to serve as the vehicle control
  • Experimental: local BQ-788 and BQ-123 perfusion
    local ET-1 inhibitors perfused through the microdialysis fiber to serve as the experimental treatment
  • Experimental: local L-NAME perfusion
    local L-NAME is perfused through the microdialysis fiber to inhibit nitric oxide synthase
  • Experimental: local BQ-788 + BQ-123 + L-NAME perfusion
    local ET-1 inhibitors and L-NAME are perfused through the microdialysis fiber to inhibit nitric oxide synthase during the experimental treatment

Primary Outcome Measure

amount of microvascular insulin-mediated dilation [ Time Frame: at the study visit, an average of 4 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of IowaIowa CityIowa52242
Anna Stanhewicz, PhD
[email protected]
319-467-1732

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By research site
University of Iowa· Iowa City, IA

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