Therapeutic Strategies to Reduce Endothelial Ischemia-reperfusion Injury

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGary Van Guilder

About this trial

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.

Eligibility criteria

Qualifiers

Sedentary men and women between the ages of 18-65 years of all races and ethnicity

Diet and weight stable for the past 3 months

Non-smoking and not using tobacco or electronic cigarettes

Disqualifiers

Use of medications known to affect cardiovascular function

Hyperlactemia

Type A lactic acidosis

Type B lactic acidosis

Trial design

Treatments tested in this trial

  • Ischemic preconditioning
  • Intravenous lactate infusion
  • No ischemic preconditioning (control)
  • Normal Saline Infusion (Placebo)
  • Ischemic preconditioning and intravenous lactate

Treatment groups

68 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Gary Van Guilder

Lead sponsor

Western Colorado University

Sponsor institution