Status:
COMPLETED
ENAC Blockade and Arterial Stiffness
Lead Sponsor:
University of Missouri-Columbia
Conditions:
Overweight and Obesity
Insulin Resistance
Eligibility:
All Genders
30-70 years
Phase:
PHASE2
PHASE3
Brief 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 exa...
Detailed Description
Overweight/obese males, pre- and post-menopausal females with insulin resistance, 30-70 years of age will be recruited. Following screening, eligible men and women will be randomly assigned to either ...
Eligibility Criteria
Inclusion
- 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
- History of type 1 or type 2 diabetes
- Known cardiovascular events within the last 12 months (stroke, acute coronary event, revascularization, heart failure hospitalization).
- 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.
- Active cancer (This criterion does not apply to those subjects with basal cell carcinoma or stage 1 squamous cell carcinoma of the skin)
- Excessive alcohol consumption (\>14 drinks/week for men, \>7 drinks/week for women)
- Current tobacco use
- Non controlled hypertension
- 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
- Potassium level \> 5.0 mqE/L at time of screening
- Blood pressure at screening \<110/70
Key Trial Info
Start Date :
July 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2025
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT03837626
Start Date
July 15 2019
End Date
April 30 2025
Last Update
December 30 2025
Active Locations (1)
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1
University of Missouri Hospital and Clinics
Columbia, Missouri, United States, 65201