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Dipeptide
Carnosine for Peripheral Arterial Disease (CAR-PAD Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Shahid Baba
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if taking L-carnosine supplements can help people with PAD improve their leg function and walk more easily by promoting new blood vessel growth and reducing muscle stress. Carnosine is a dipeptide stored in muscle and brain tissue, known for its antioxidant properties and potential benefits in managing peripheral vascular disease.
Who is the study for?
This trial is for men aged 50-80 with Peripheral Arterial Disease, having an ABI of 0.4 to less than 0.60, and who can follow the study rules. They must be White or African American, speak English, and give informed consent. It's not for those with severe diseases like HIV or cancer, carnosinemia, allergies to L-carnosine/meat, pacemakers/metal implants, recent major injuries/amputations/ulcers or uncontrolled diabetes.
What is being tested?
The trial tests if taking L-carnosine pills helps improve leg function in PAD patients by increasing muscle carnosine levels and promoting new blood vessel growth.
What are the potential side effects?
Potential side effects are not explicitly listed but may include allergic reactions to L-carnosine or issues related to increased muscle carnosine levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Carnosine for Peripheral Arterial Disease patients
Secondary study objectives
Graded treadmill test
Side effects data
From 2012 Phase 2 trial • 33 Patients • NCT008103688%
Hypergammaglobulinemia
8%
Costochondritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Carnosine Treatment Group
Placebo Control Group
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Carnosine intervention for patients with PADExperimental Treatment1 Intervention
This is a single arm open labelled safety trial, where we will supplement carnosine for 3 months to subjects with non-claudication and claudication peripheral arterial disease (PAD), and determine if it improves walking ability.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carnosine
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Shahid BabaLead Sponsor
1 Previous Clinical Trials
120 Total Patients Enrolled
1 Trials studying Peripheral Arterial Disease
120 Patients Enrolled for Peripheral Arterial Disease
University of LouisvilleLead Sponsor
345 Previous Clinical Trials
77,395 Total Patients Enrolled
1 Trials studying Peripheral Arterial Disease
10 Patients Enrolled for Peripheral Arterial Disease
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have HIV, hepatitis, severe liver disease, active infection, anemia, organ transplant, kidney disease needing dialysis, lung disease needing oxygen, serious heart disease from birth, any type of cancer, or untreated thyroid disease.You have been diagnosed with carnosinemia.You are allergic to L-carnosine or meat.You have a pacemaker.You have obesity caused by a known genetic problem.You have dementia.You have severe blockage in the blood vessels of your leg, and have had an amputation below or above the knee.You have ulcers on your feet.You have had a major limb removed.You have severe kidney disease.You have any metal implants in your body.Your ankle-brachial index (ABI) is between 0.4 and less than 0.60.You had a major injury within the last 30 days before joining the study.Your diabetes is not well controlled, with a high HbA1C level above 9%.Men between 50 and 80 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Carnosine intervention for patients with PAD
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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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