NCT03837626

ENAC Blockade and Arterial Stiffness

Estrogen Receptor Alpha Signaling in Endothelial Cells Exacerbates Arterial Stiffening Via Upregulation of ENaC in Insulin Resistant Females

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: University of Missouri-Columbia · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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 amiloride (max dose 5mg) or placebo in a double-blinded design manner. 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

• Overweight and Obesity
• Insulin Resistance

Interventions

Type	Name	Description
DRUG	Placebo - Cap	6 months of 1 pill a day
DRUG	Amiloride Pill	Max dose of 5 mg a day for 6 months

Timeline

• Start date: 2019-07-15
• Primary completion: 2024-10-05
• Completion: 2025-04-30
• First posted: 2019-02-12
• Last updated: 2025-12-30
• Results posted: 2025-12-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study