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

What Was Tested

The trial (early phase 1) is built around Insulin Aspart.

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.

It had four arms (groups): local lactated Ringer's perfusion (placebo comparator), local BQ-788 and BQ-123 perfusion (experimental), local L-NAME perfusion (experimental) and local BQ-788 + BQ-123 + L-NAME perfusion (experimental).

Lactated Ringer's is perfused through the microdialysis fiber to serve as the vehicle control.

Local ET-1 inhibitors perfused through the microdialysis fiber to serve as the experimental treatment.

Local L-NAME is perfused through the microdialysis fiber to inhibit nitric oxide synthase.

The registry classes the interventions as drug.

Who Took Part

The registry lists 40 planned participants were the target.

It was open to women only aged from 18 years up to 50 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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.

The full record lists 2 inclusion and 10 exclusion criteria; among the exclusions: skin diseases,; current tobacco or electronic cigarette/vape pen use,; diagnosed or suspected hepatic or metabolic disease including diabetes,.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Insulin Aspart study: the participants and staff both knew the treatment.

It started in 2024-10-01 with completion listed for 2026-09.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: amount of microvascular insulin-mediated dilation (time frame: at the study visit, an average of 4 hours).

What This Means in Plain Language

Put simply, this is a early phase 1, non-randomized trial of Insulin Aspart in 40 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Aspart compound page, all human trials.