Overview

Carnosine for Peripheral Arterial Disease

Status:
Suspended

Trial end date:
2023-07-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Louisville

Criteria

Inclusion Criteria:

1. Subjects between 50 and 80 years of age.

2. English Speaking.

3. ABI 0.3 -<0.90 (in at least one leg).

4. Willing to comply with protocol requirements.

5. Able to provide informed consent.

6. Able to walk on a treadmill for more than 2 minutes -

Exclusion Criteria:

1. Subjects with HIV, hepatitis, significant liver disease, active infection, anemia,
organ transplant, renal disease requiring dialysis, lung disease requiring oxygen,
significant congenital heart disease, cancer of any type, and untreated thyroid
disease.

2. Diagnosis of carnosinemia.

3. Known allergy to L-carnosine or meat.

4. Obesity from a known genetic defect.

5. Dementia.

6. Critical limb ischemia with below or above knee amputations.

7. Foot ulcers.

8. Major amputations.

9. Participating in other clinical trials.

10. End stage renal disease.

11. Presence of significant injury within 30 days before enrollment.

12. Prisoners

13. Poorly controlled diabetes (HbA1C >9%).

14. Able to walk for more than 12 minutes.

15. Currently taking Pletal (cilostazol) or Trentol (pentoxifylline) -