NCT06825143

Therapeutic Strategies to Reduce Endothelial Ischemia-reperfusion Injury

Not yet recruiting EARLY_PHASE1 Last updated 13 February 2025

What this trial tests

EARLY_PHASE1 trial testing Ischemic preconditioning in Metabolic Syndrome in 68 participants. Not yet recruiting.

Timeline

1 October 2026

Primary endpoint
30 September 2029

30 June 2030

Quick facts

Lead sponsor	Gary Van Guilder
Phase	EARLY_PHASE1
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	68
Start date	1 October 2026
Primary completion	30 September 2029
Estimated completion	30 June 2030
Sites	1 location across United States

Drugs / interventions tested

• Ischemic preconditioning — full drug profile →
• Intravenous lactate infusion
• No ischemic preconditioning (control)
• Normal Saline Infusion (Placebo)
• Ischemic preconditioning and intravenous lactate

Conditions studied

• Metabolic Syndrome — all drugs for Metabolic Syndrome →
• Vascular Injury — all drugs for Vascular Injury →
• Ischemic Preconditioning — all drugs for Ischemic Preconditioning →
• Endothelial Function (reactive Hyperemia) — all drugs for Endothelial Function (reactive Hyperemia) →

Sponsor

Gary Van Guilder

Who can join

Adults 18 to 65, any sex, with Metabolic Syndrome or Vascular Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of this clinical trial is to better understand how lactate, a naturally occurring energy substance, can be used to lessen damage to the vascular system in adults with a high cardiovascular disease risk.

The main questions it aims to answer are:

1. Does giving lactate intravenously reduce injury to the vascular system?
2. Does giving lactate intravenously together with blood flow occlusion - known as ischemic preconditioning, reduce vascular injury better than blood flow occlusion by itself?
3. How does lactate help the vascular system?

Researchers will compare lactate to a placebo (a look-alike substance that contains no lactate) to see if lactate works to lessen vascular injury.

Researchers will also compare lactate to blood flow occlusion to see which one is better at preventing vascular injury.

Researchers will also compare lactate and blood flow occlusion together to see if combining them works better than either one alone.

In one visit to the laboratory, participants will:

Obtain a measurement of vascular health in an arm Be given liquid lactate, a liquid placebo, and/or arm blood flow occlusion Obtain a second measurement of vascular health in an arm.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.