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

A

Anna Stanhewicz, PhD

Status and phase

Not yet enrolling
Early Phase 1

Conditions

Gestational Diabetes
Physical Inactivity
Endothelial Dysfunction

Treatments

Drug: Insulin aspart

Study type

Interventional

Funder types

Other

Identifiers

NCT06547619
202405270

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 4 patient groups, including a placebo group

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

Trial contacts and locations

0

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Central trial contact

Anna Reid-Stanhewicz, PHD

Data sourced from clinicaltrials.gov

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