Carnosine for Peripheral Arterial Disease

NCT04870229 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 16.0047
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 1.Determine whether carnosine supplementation improves the pain-free treadmill walking ability of the subjects supplemented with carnosine compared to placebo.
2. 2.Compare the levels of carnosine, VEGF, HIF-1α, and PHDs activity in the skeletal muscle before and after placebo and carnosine supplementation.
3. 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. 4.Explore the effects of race and gender on VEG, carnosine, and HIF-1α levels in both groups.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Walking Endurance

  Compare effects of carnosine and placebo supplementation on the 6MWT in patient with and without claudication

  6 months

Secondary Outcomes (1)

• Graded treadmill test

  6 months

Study Arms (2)

Carnosine

ACTIVE COMPARATOR

Each participant will be given a daily oral dose 1g of methycellulose powder for 6 months

Drug: Carnosine

Placebo

PLACEBO COMPARATOR

Each participant will be given a daily oral dose 1g of placebo for 6 months

Drug: Placebo

Interventions

Carnosine DRUG

Carnosine

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects between 50 and 80 years of age.
• English Speaking.
• ABI 0.3 -\<0.90 (in at least one leg).
• Willing to comply with protocol requirements.
• Able to provide informed consent.
• Able to walk on a treadmill for more than 2 minutes -

You may not qualify if:

• 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.
• Diagnosis of carnosinemia.
• Known allergy to L-carnosine or meat.
• Obesity from a known genetic defect.
• Dementia.
• Critical limb ischemia with below or above knee amputations.
• Foot ulcers.
• Major amputations.
• Participating in other clinical trials.
• End stage renal disease.
• Presence of significant injury within 30 days before enrollment.
• Prisoners
• Poorly controlled diabetes (HbA1C \>9%).
• Able to walk for more than 12 minutes.
• Currently taking Pletal (cilostazol) or Trentol (pentoxifylline) -

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Carnosine

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Dipeptides; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Shahid P Baba, PhD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: May 3, 2021
• Study Start: May 12, 2016
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)