Lactate and Ischemic Preconditioning for Vascular Injury

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Gary Van Guilder

No Placebo Group

Trial Summary

What is the purpose of 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

Adults at high risk for cardiovascular disease who may have conditions like Arterial Tortuosity Syndrome or Metabolic Syndrome. Participants should not have any health issues that could interfere with the trial, such as severe bleeding disorders or recent heart attacks.

Inclusion Criteria

Diet and weight stable for the past 3 months

Non-smoking and not using tobacco or electronic cigarettes

I am between 18 and 65 years old and lead a sedentary lifestyle.

Exclusion Criteria

Metabolic acidosis

Body mass index greater than or equal to 35

Currently pregnant, recent pregnancy, or breast-feeding

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Treatment Details

Interventions

Intravenous Lactate Infusion (Other)
Ischemic Preconditioning (Other)

Trial OverviewThe trial is testing if intravenous lactate can reduce vascular injury compared to a saline placebo and whether combining lactate with ischemic preconditioning (blood flow occlusion) offers greater protection than either treatment alone.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Ischemic preconditioning combined with an intravenous lactate infusionExperimental Treatment2 Interventions

To goal of this Arm is to compare the capacity of ischemic preconditioning (IPC) combined with an intravenous lactate infusion to protect against endothelial ischemia/reperfusion injury to IPC by itself. To achieve this goal, investigators will test the hypothesis that the capacity to protect against endothelial injury will be better when IPC and lactate are combined compared to IPC alone. Participants will be randomized to one of two Interventions. One Intervention will be the IPC intervention by itself. The other intervention will be adding an intravenous lactate infusion together with IPC which is the main focus of the study.

Group II: Ischemic preconditioning versus intravenous lactate infusionActive Control4 Interventions

To goal of this Arm is to compare the capacity of ischemic preconditioning (IPC) to protect against endothelial ischemia/reperfusion injury to the capacity of an intravenous lactate infusion to protect against endothelial ischemia/reperfusion injury. To achieve this goal, investigators will test the hypothesis that the capacity for intravenous lactate to reduce endothelial injury will be equivalent to that of IPC. Participants will be randomized to one of two Interventions. One Intervention will be the IPC intervention which is thought to be effective in treating the condition under study. The other intervention is the intravenous lactate intervention, which is the main focus of the study.