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ENaC inhibitor
Amiloride for Arterial Stiffness in Obesity
Phase 2 & 3
Waitlist Available
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
Must not have
Chronic use of NSAIDs
Pregnancy or lactation in women (or women not using contraceptives)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months (interim) and 6 months (final)
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.
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.
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 belowSelect...
I am between 30 and 70 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I regularly take NSAIDs for pain or inflammation.
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I am not pregnant, breastfeeding, or if I am a woman capable of becoming pregnant, I am using contraception.
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I have a history of diabetes (type 1 or 2).
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My blood pressure is not well-controlled.
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I haven't had a heart attack, stroke, or heart surgery in the last year.
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I do not have uncontrolled thyroid, severe liver disease, or severely reduced kidney function.
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I am taking medication or supplements that affect my potassium levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months (interim) and 6 months (final)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months (interim) and 6 months (final)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Carotid femoral PWV
Secondary study objectives
Brachial artery flow mediated dilation (FMD)
Popliteal artery flow mediated dilation (FMD)
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
379 Previous Clinical Trials
628,337 Total Patients Enrolled
10 Trials studying Insulin Resistance
207 Patients Enrolled for Insulin Resistance
Camila Manrique Acevedo, MDPrincipal InvestigatorUniversity of Missouri-Columbia
2 Previous Clinical Trials
86 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You currently smoke or use tobacco.I regularly take NSAIDs for pain or inflammation.I am not pregnant, breastfeeding, or if I am a woman capable of becoming pregnant, I am using contraception.I have a history of diabetes (type 1 or 2).My blood pressure is not well-controlled.I haven't had a heart attack, stroke, or heart surgery in the last year.Your potassium level is higher than 5.0 mqE/L when tested.I am between 30 and 70 years old.Your blood pressure is lower than 110/70.I do not have uncontrolled thyroid, severe liver disease, or severely reduced kidney function.Your body mass index (BMI) is between 25.1 and 50, or your waist size is over 88 cm (35 inches) if you're a woman, or over 102 cm (40 inches) if you're a man.You have high triglycerides, low "good" cholesterol, high blood pressure, or high blood sugar levels.I have active cancer, not including basal cell or early-stage squamous cell skin cancer.You exercise regularly for more than 3 days a week at a medium or high level of effort.You drink more than 14 drinks per week if you are a man, or more than 7 drinks per week if you are a woman.I am taking medication or supplements that affect my potassium levels.
Research Study Groups:
This trial has the following groups:- Group 1: Amiloride
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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