Therapeutic Strategies to Reduce Endothelial Ischemia-reperfusion Injury
Starting soon · Early Phase 1 · Has a placebo group
Conditions studied: Metabolic Syndrome, Vascular Injury, Ischemic Preconditioning, Endothelial Function (reactive Hyperemia), Endothelial Dysfunction
In brief
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.
Key facts
- Study ID
- NCT06825143
- Run by
- Gary Van Guilder
- People needed
- 68
- Starts
- 2026-10-01
- Expected to finish
- 2030-06-30
- Last updated by the study team
- 2025-02-13
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- High Altitude Physiology Laboratory at Western Colorado University — Gunnison, Colorado, United States
Full record on ClinicalTrials.gov
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