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Trial record 11 of 264 for:    Estrogen Resistance

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
Sponsor:
Information provided by (Responsible Party):
Camila Manrique, University of Missouri-Columbia

Tracking Information
First Submitted Date  ICMJE February 8, 2019
First Posted Date  ICMJE February 12, 2019
Last Update Posted Date September 6, 2019
Estimated Study Start Date  ICMJE September 4, 2019
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03837626 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2019)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ENAC Blockade and Arterial Stiffness
Official Title  ICMJE Estrogen Receptor Alpha Signaling in Endothelial Cells Exacerbates Arterial Stiffening Via Upregulation of ENaC in Insulin Resistant Females
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 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 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Overweight and Obesity
  • Insulin Resistance
Intervention  ICMJE
  • Drug: Placebo - Cap
    6 months of 1 pill a day
  • Drug: Amiloride Pill
    5 mg day for 6 months
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    6 months of daily placebo
    Intervention: Drug: Placebo - Cap
  • Experimental: Amiloride
    6 months of amiloride 5 mg treatment
    Intervention: Drug: Amiloride Pill
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 8, 2019)
157
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2024
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 30 to 70 years of age at randomization
  • Body mass index (BMI) 25.1-40 kg/m2 (weight stable during the prior 6 months)2 or waist circumference > 88 cm (> 35 in) in women and >102 cm (>40 in) in men. 3, 4
  • Pre-diabetes (fasting blood glucose 100-125 mg/dl or between 140-200 mg/dL 2 hours after OGTT glucose load).
  • Fasting insulin level >10 U/mL (correlates with insulin resistance).

Exclusion Criteria:

  1. Known cardiovascular disease (CVD), unstable angina, abnormal thyroid tests or liver disease, renal disease (GFR <60 ml/min)
  2. Use of diuretics, potassium sparing medications (angiotensin II receptor blockers. Angiotensin converting enzymes inhibitors or mineralocorticoid receptor blockers) or use of potassium supplements.
  3. Active cancer
  4. Autoimmune diseases
  5. Excessive alcohol consumption (>14 drinks/week for men, >7 drinks/week for women)
  6. Current tobacco use
  7. Body weight change ≥10% within the last 6 months
  8. Non controlled hypertension
  9. Surgical history for weight loss or use of weight-loss medications or active dieting
  10. Participation in exercise > 3 days/wk per week at a moderate or vigorous intensity
  11. Pregnancy or lactation in women (or women not using contraceptives)
  12. Women who plan to become pregnant during the duration of the trial
  13. Chronic use of NSAIDs
  14. Potassium level > 5.0 mqE/L at time of screening
  15. Blood pressure at screening <110/70

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Camila Manrique Acevedo, MD 573-8820999 manriquec@health.missouri.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03837626
Other Study ID Numbers  ICMJE 2012990
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Camila Manrique, University of Missouri-Columbia
Study Sponsor  ICMJE University of Missouri-Columbia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Camila Manrique Acevedo, MD University of Missouri-Columbia
PRS Account University of Missouri-Columbia
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP