Recruiting
Early Phase 1

Observational Study

Sponsor:

Anna Stanhewicz, PhD

Code:

NCT06547619

Conditions

Gestational Diabetes

Endothelial Dysfunction

Physical Inactivity

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Insulin aspart

Study Details

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.

Conditions

Gestational Diabetes

Endothelial Dysfunction

Physical Inactivity

Study ID

NCT06547619

Start date

Oct 1, 2024

Status verified date

Jul, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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

Interventions

Insulin aspart

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

More Information

Sponsor

Anna Stanhewicz, PhD

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Anna Stanhewicz, PhD on 2026-07-29.