Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
137 participants
INTERVENTIONAL
2019-07-15
2025-04-30
Brief Summary
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Detailed Description
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After randomization, subjects will be scheduled for an outpatient visit to the undergo baseline assessment of arterial stiffness (carotid femoral pulse wave velocity - cfPWV) and endothelial function (brachial popliteal artery flow mediated dilation). Subject assessment will be repeated at 12 weeks and at 24 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
6 months of daily placebo
Placebo - Cap
6 months of 1 pill a day
Amiloride
6 months of amiloride (max dose 5 mg) treatment
Amiloride Pill
Max dose of 5 mg a day for 6 months
Interventions
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Placebo - Cap
6 months of 1 pill a day
Amiloride Pill
Max dose of 5 mg a day for 6 months
Eligibility Criteria
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Inclusion Criteria
* 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
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 (This criterion does not apply to those subjects with basal cell carcinoma or stage 1 squamous cell carcinoma of the skin)
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
30 Years
70 Years
ALL
No
Sponsors
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University of Missouri-Columbia
OTHER
Responsible Party
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Camila Manrique, MD
Associate Professor, Endocrinology
Principal Investigators
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Camila Manrique Acevedo, MD
Role: PRINCIPAL_INVESTIGATOR
University of Missouri-Columbia
Locations
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University of Missouri Hospital and Clinics
Columbia, Missouri, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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2012990
Identifier Type: -
Identifier Source: org_study_id