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Carnosine for Peripheral Arterial Disease

NCT04870229 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-08-04

No results posted yet for this study

Summary

The hypothesis is that oral supplementation of L-carnosine will inhibit PHDs, increase HIF1-translocation and angiogenesis and thus improve the functioning of lower extremities in PAD patients.

Primary Aim:

1\. Compare the effect of carnosine and placebo supplementation on the 6MWT in PAD patients with and without claudication.

Secondary Aim:

1. Determine whether carnosine supplementation improves the pain-free treadmill walking ability of the subjects supplemented with carnosine compared to placebo.
2. Compare the levels of carnosine, VEGF, HIF-1α, and PHDs activity in the skeletal muscle before and after placebo and carnosine supplementation.
3. Compare the levels of EPCs (CD34+/CD133+), inflammatory markers (serum amyloid A, hsCRP) and thrombotic markers (fibrinogen, homocysteine) as cardiovascular risk markers in these subjects.
4. Explore the effects of race and gender on VEG, carnosine, and HIF-1α levels in both groups.

Conditions

  • Peripheral Arterial Disease

Interventions

DRUG

Carnosine

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • University of Louisville

    lead OTHER

Principal Investigators

  • Shahid P Baba, PhD · University of Louisville

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-12
Primary Completion
2022-07-31
Completion
2022-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04870229 on ClinicalTrials.gov