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NCT04870229 · ClinicalTrials.gov registry record · Phase 2
Carnosine for Peripheral Arterial Disease
A Phase 2 study, sponsored by University of Louisville.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT04870229 is a Phase 2 study that has completed, run by University of Louisville. The registered enrollment target is 10 participants.
The verdict
NCT04870229, a Phase 2 study, has completed, sponsored by University of Louisville.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
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.
Interventions
- DRUG Placebo
- DRUG Carnosine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2016-05-12 |
| Est. Completion | 2022-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04870229
The ClinicalTrials.gov registry entry for NCT04870229 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Louisville, which has 217 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04870229 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04870229 about?
NCT04870229 is a clinical study titled "Carnosine for Peripheral Arterial Disease". 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...
What is the current status of trial NCT04870229?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2016-05-12. Estimated completion is 2022-07.
What interventions are being tested in trial NCT04870229?
The interventions under investigation include: Placebo (DRUG), Carnosine (DRUG).
Who is sponsoring clinical trial NCT04870229?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
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