NCT03837626CompletedPhase 2/3
ENAC Blockade and Arterial Stiffness
Estrogen Receptor Alpha Signaling in Endothelial Cells Exacerbates Arterial Stiffening Via Upregulation of ENaC in Insulin Resistant Females
Source: ClinicalTrials.gov · Last updated 30 Dec 2025
Brief summary (registry, in English)
To determine whether treatment with the ENaC inhibitor, amiloride, improves endothelial function and arterial stiffness in obese insulin resistant subjects in a randomized placebo-controlled trial examining pre and postmenopausal women and age-matched men.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 137 (actual)
- First submitted
- 8 Feb 2019
- Start date
- 15 Jul 2019
- Primary completion date
- 5 Oct 2024
- Lead sponsor
- University of Missouri-Columbia
- Diseases
- Obesity
- NCT number
- NCT03837626
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 137
- From 15 Jul 2019 to the primary completion date, 5 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of type 1 or type 2 diabetes
- Known cardiovascular events within the last 12 months (stroke, acute coronary event, revascularization, heart failure hospitalization).
- Active cancer (This criterion does not apply to those subjects with basal cell carcinoma or stage 1 squamous cell carcinoma of the skin)
- Non controlled hypertension
Lab values
- History of uncontrolled thyroid disease, chronic liver disease (cirrhosis) or GFR \<50 ml/min.
- Use of potassium sparing medications (angiotensin II receptor blockers, angiotensin converting enzymes inhibitors or mineralocorticoid receptor blockers) or use of potassium supplements.
- Potassium level \> 5.0 mqE/L at time of screening
Other
- Excessive alcohol consumption (\>14 drinks/week for men, \>7 drinks/week for women)
- Current tobacco use
- Participation in regular exercise \> 3 days/wk per week at a moderate or vigorous intensity
- Pregnancy or lactation in women (or women not using contraceptives)
- Women who plan to become pregnant during the duration of the trial
- Chronic use of NSAIDs
- Blood pressure at screening \<110/70
Who the study is looking for
- 30 to 70 years of age at randomization
- Body mass index (BMI) 25.1-50 kg/m2 or waist circumference \> 88 cm (\> 35 in) in women and \>102 cm (\>40 in) in men. 3, 4
- One other characteristic of metabolic syndrome (elevated triglycerides ≥150 mg/dl; HDL cholesterol \<40 mg/dl in men and \<50 mg/dl in women; blood pressure ≥130/85 mm Hg or treatment for hypertension; impaired fasting glucose (≥100 mg/dl)) or fasting insulin level \>10 mU/L (correlates with insulin resistance).
Age in the registry: 30 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Missouri Hospital and Clinics Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.