Therapeutic Strategies to Reduce Endothelial Ischemia-reperfusion Injury
United States68 participantsStarted 2026-10-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Use of medications known to affect cardiovascular function
* Hyperlactemia
* Type A lactic acidosis
* Type B lactic acidosis
* Extracellular hyperhydration or hypervolemia
* Hyperkaliemia
* Hypercalcemia
* Metabolic alkalosis
* Metabolic acidosis
* McArdle's Disease
* Diabetes Type 1 and 2
* Taking oral contraceptives or hormone replacement therapy
* Body mass index greater than or equal to 35
* Smoking or using smokeless tobacco and electronic cigarettes
* Cardiovascular, cerebrovascular, liver, respiratory, and renal disease
* Atrial fibrillation or other sustained supraventricular/ventricular arrhythmia
* Familial hypercholesterolemia
* Rheumatoid arthritis
* Sleep apnea
* Currently pregnant, recent pregnancy, or breast-feeding
* Autonomic nervous system dysfunction
* Raynaud's disease
* Active malignancy excluding basal cell carcinoma of the skin
* Three or more days of at least 30 minutes of aerobic exercise in the past 3 months
* Inability to provide consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Baseline value of the mean peak forearm blood flow response to reactive hyperemia.
Timeframe: Baseline (time 0)
2
Mean peak forearm blood flow response to reactive hyperemia at 3 hours.