ENAC Blockade and Arterial Stiffness
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|ClinicalTrials.gov Identifier: NCT03837626|
Recruitment Status : Recruiting
First Posted : February 12, 2019
Last Update Posted : September 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Overweight and Obesity Insulin Resistance||Drug: Placebo - Cap Drug: Amiloride Pill||Phase 2 Phase 3|
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 5 mg 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 artery flow mediated dilation ). Subject assessment will be repeated at 12 weeks and at 24 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||157 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Estrogen Receptor Alpha Signaling in Endothelial Cells Exacerbates Arterial Stiffening Via Upregulation of ENaC in Insulin Resistant Females|
|Estimated Study Start Date :||September 4, 2019|
|Estimated Primary Completion Date :||June 2024|
|Estimated Study Completion Date :||June 2024|
Placebo Comparator: Placebo
6 months of daily placebo
Drug: Placebo - Cap
6 months of 1 pill a day
6 months of amiloride 5 mg treatment
Drug: Amiloride Pill
5 mg day for 6 months
- Carotid femoral PWV [ Time Frame: Baseline, 3 months (interim) and 6 months (final) ]It is the gold standard non-invasive index of arterial stiffness. Transit time between carotid and femoral pressure waves is calculated using the foot-to-foot method. cfPWV is calculated as distance traveled by the pulse wave (i.e., femoral location-sternal notch minus sternal notch-carotid location) divided by pulse transit time. All the measurements will be done by the same blinded technician.The goal is to assess changes from baseline when compared to interim and final time point.
- Brachial artery flow mediated dilation (FMD) [ Time Frame: Baseline, 3 months (interim) and 6 months (final) ]The goal is to assess changes from baseline when compared to interim and final time point. ] Brachial artery FMD will be assessed at baseline and at 12-wk. FMD is a measurement of conduit artery endothelial function. FMD is assessed immediately after each PWV measurement. Shear rate AUC until peak diameter is calculated as stimulus for FMD and used in covariate analysis as described. All measurements will be performed, under co-I supervision by the same blinded technician.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03837626
|Contact: Camila Manrique Acevedo, MDemail@example.com|
|United States, Missouri|
|University of Missouri Hospital and Clinics||Recruiting|
|Columbia, Missouri, United States, 65201|
|Contact: Camila Manrique 573-882-2273 firstname.lastname@example.org|
|Principal Investigator:||Camila Manrique Acevedo, MD||University of Missouri-Columbia|