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ENaC inhibitor

Amiloride for Arterial Stiffness in Obesity

Phase 2 & 3
Recruiting
Led By Camila Manrique Acevedo, MD
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
30 to 70 years of age at randomization
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months (interim) and 6 months (final)
Awards & highlights

Study Summary

This trial will test whether the ENaC inhibitor amiloride can improve endothelial function and arterial stiffness in obese, insulin resistant subjects. The trial will involve pre and postmenopausal women and age-matched men.

Who is the study for?
This trial is for obese or overweight adults aged 30-70 with a BMI of 25.1-50 kg/m2 or certain waist measurements, plus one other metabolic syndrome feature like high triglycerides. It's not for smokers, heavy drinkers, those on specific heart/kidney medications, diabetics, very active individuals, pregnant/breastfeeding women, and people with recent severe health issues.Check my eligibility
What is being tested?
The study tests if amiloride (an ENaC blocker) can improve blood vessel function and reduce artery stiffness in obese insulin-resistant subjects compared to a placebo. The participants are pre/postmenopausal women and age-matched men who will be randomly assigned to the treatments.See study design
What are the potential side effects?
Possible side effects of amiloride include elevated potassium levels which could affect heart rhythm, dizziness due to low blood pressure especially after standing up quickly from sitting/lying down positions, muscle cramps or weakness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 30 and 70 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months (interim) and 6 months (final)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months (interim) and 6 months (final) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Carotid femoral PWV
Secondary outcome measures
Brachial artery flow mediated dilation (FMD)
Popliteal artery flow mediated dilation (FMD)

Side effects data

From 2017 Phase 1 trial • 42 Patients • NCT03031496
8%
Headache
3%
Crystal Urine
3%
Hyperkalaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment A
Treatment B

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AmilorideExperimental Treatment1 Intervention
6 months of amiloride (max dose 5 mg) treatment
Group II: PlaceboPlacebo Group1 Intervention
6 months of daily placebo

Find a Location

Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor
362 Previous Clinical Trials
627,957 Total Patients Enrolled
10 Trials studying Insulin Resistance
231 Patients Enrolled for Insulin Resistance
Camila Manrique Acevedo, MDPrincipal InvestigatorUniversity of Missouri-Columbia
2 Previous Clinical Trials
86 Total Patients Enrolled

Media Library

Amiloride (ENaC inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03837626 — Phase 2 & 3
Insulin Resistance Research Study Groups: Amiloride, Placebo
Insulin Resistance Clinical Trial 2023: Amiloride Highlights & Side Effects. Trial Name: NCT03837626 — Phase 2 & 3
Amiloride (ENaC inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03837626 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does scientific literature support the use of Amiloride Pill?

"There are a total of 8 clinical trials currently underway for Amiloride Pill. 2 of those trials have advanced to Phase 3. Although most of the research is based in Birmingham and Cambridgeshire, there are 20 different locations running these tests."

Answered by AI

Are there any remaining vacancies for participants in this clinical trial?

"This trial, as listed on clinicaltrials.gov, is actively recruiting participants. It was first posted on July 15th, 2019 and was last updated on May 19th, 2022."

Answered by AI

Would elderly patients be able to participate in this research?

"The age range for participants in this trial are individuals that are over 30 and below 70 years old."

Answered by AI

How many people are volunteering to participate in this experiment?

"Yes, the research team is currently looking for volunteers to participate in this study. According to the information available on clinicaltrials.gov, the trial was first posted on 7/15/2019 and has since been edited on 5/19/2022. So far, 157 people have signed up at the single location where this study is taking place."

Answered by AI

What are some conditions that Amiloride Pill is known to improve?

"Amiloride Pills are most often used to lower blood pressure in patients with hypertensive disease. However, this medication can also be given to those suffering from nephrolithiasis, congestive heart failure (chf), and polyuria."

Answered by AI

Could I possibly take part in this research?

"This clinical trial is currently enrolling 157 patients that suffer from insulin resistance and are between 30-70 years old. The most important criteria for applicants are as follows: being aged 30 to 70 years old at randomization, having a Body mass index (BMI) of 25.1-50 kg/m2 or waist circumference > 88 cm (> 35 in) if you are a woman and >102 cm (>40 in) if you are a man."

Answered by AI
~3 spots leftby Jun 2024