drugset / Trial / NCT04870229

Carnosine for Peripheral Arterial Disease

NCT04870229 ↗

Phase 2 Completed 10 enrolled University of Louisville
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2016-05-12
Primary completion
2022-07
Completion
2022-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carnosine Peptide 1 g Oral