Therapeutic Strategies to Reduce Endothelial Ischemia-reperfusion Injury
Launched by GARY VAN GUILDER · Feb 7, 2025
Trial Information
Current as of July 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring a treatment using lactate, a natural substance in our bodies that helps produce energy, to see if it can reduce damage to blood vessels in adults who are at high risk for heart disease. The researchers want to find out if giving lactate through an IV can help protect the vascular system, especially when combined with a method that temporarily cuts off blood flow to the arm, known as ischemic preconditioning. They will compare the effects of lactate, a placebo (a substance that looks like lactate but has no active ingredients), and the blood flow occlusion to see which is most effective in preventing vascular injury.
To be eligible for this trial, participants should be sedentary adults aged 18 to 65 who have maintained a stable diet and weight for the past three months and do not smoke. During a single visit to the lab, participants will have their vascular health measured, receive either lactate or a placebo, and experience blood flow occlusion, followed by another measurement of their vascular health. It’s important to know that individuals with certain health conditions, like diabetes or significant weight issues, or those taking specific medications, will not be able to participate. This trial is not yet recruiting, but it aims to provide valuable insights into improving vascular health for those at risk of cardiovascular issues.
Gender
ALL
Eligibility criteria
- 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
About Gary Van Guilder
Gary Van Guilder is a dedicated clinical trial sponsor with a proven track record in advancing medical research and innovation. With a focus on developing and managing clinical studies across various therapeutic areas, he is committed to ensuring the highest standards of safety, efficacy, and regulatory compliance. Leveraging a robust network of industry partnerships and a deep understanding of clinical trial methodologies, Gary Van Guilder strives to facilitate the successful translation of scientific discoveries into meaningful treatments for patients. His leadership and expertise contribute significantly to the advancement of healthcare solutions and the enhancement of patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Gunnison, Colorado, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported