Overview

ENAC Blockade and Arterial Stiffness

Status:
Recruiting
Trial end date:
2024-06-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Missouri-Columbia
Treatments:
Amiloride
Criteria
Inclusion Criteria:

- 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).

Exclusion Criteria:

1. History of type 1 or type 2 diabetes

2. Known cardiovascular events within the last 12 months (stroke, acute coronary event,
revascularization, heart failure hospitalization).

3. History of uncontrolled thyroid disease, chronic liver disease (cirrhosis) or GFR <50
ml/min.

4. Use of potassium sparing medications (angiotensin II receptor blockers, angiotensin
converting enzymes inhibitors or mineralocorticoid receptor blockers) or use of
potassium supplements.

5. Active cancer

6. Excessive alcohol consumption (>14 drinks/week for men, >7 drinks/week for women)

7. Current tobacco use

8. Non controlled hypertension

9. Participation in regular exercise > 3 days/wk per week at a moderate or vigorous
intensity

10. Pregnancy or lactation in women (or women not using contraceptives)

11. Women who plan to become pregnant during the duration of the trial

12. Chronic use of NSAIDs

13. Potassium level > 5.0 mqE/L at time of screening

14. Blood pressure at screening <110/70