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Carnosine for Peripheral Vascular Disease

NCT03844113 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2020-12-29

No results posted yet for this study

Summary

The investigators hypothesise that a home-based standardised exercise intervention with 2g of carnosine daily for 6 months will improve walking endurance in 104 patients with PVD aged 40-80 years compared to placebo and exercise through stabilisation of HIF1-α in the ischaemic leg.

Aims

Aim 1: Determine whether in patients with PVD, carnosine in addition to exercise improves:

1. walking endurance (6-min walk test; primary outcome);
2. initial claudication distance (ICD), and absolute claudication distance (ACD; treadmill), cadence, resting and exercise ABI; and
3. central blood pressure, endothelial function, arterial (aortic) stiffness, lipid profile; and
4. quality of life as determined by EuroQol-5D (all secondary outcomes).
5. Improve cognitive function (global cognitive score formed by a composite of 7 cognitive tests)

Aim 2: Delineate the mechanisms by which carnosine improves walking endurance:

1. protein expression of pro-angiogenic and carnosine related genes, including carnosine transporters in the skeletal muscle biopsies, EPCs in peripheral blood and quantitative proteomic studies.
2. other mechanisms demonstrated in animal studies including plasma inflammatory markers, serum and urinary advanced glycation (AGE) and lipoxidation (ALE) end-products (tertiary outcomes).

This trial will provide evidence for use of carnosine as a therapeutic intervention for PVD patients and, if positive, will have immediate clinical application.

Conditions

  • Peripheral Arterial Disease

Interventions

DRUG

Carnosine

Each participant will be given a daily oral dose 2 g of carnosine for 6 months

DRUG

Placebo

Each participant will be given a daily oral dose 2 g of methycellulose powder for 6 months

Sponsors & Collaborators

Principal Investigators

  • Barbora deCourten, MD,PHD,MPH · Monash University and Monash Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Australia

Study Locations

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Drugs
Companies

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 NCT03844113 on ClinicalTrials.gov