Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Insulin aspart.
- Who it may be relevant to
- Registry conditions: Gestational Diabetes, Endothelial Dysfunction, Physical Inactivity. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug Insulin aspart
insulin aspart is perfused at 5 ascending concentrations (10\^-8M - 10\^-4 M) for 10 minutes each
Primary outcome measures
- amount of microvascular insulin-mediated dilation [Time frame: at the study visit, an average of 4 hours]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University of Iowa — Iowa City
Identifiers
NCT: NCT06547619 · 202405270 · F31HL177925