Metabolic SyndromeEarly Phase 1NCT06825143
Therapeutic Strategies to Reduce Endothelial Ischemia-reperfusion Injury
A Early Phase 1 study testing Ischemic preconditioning, Intravenous lactate infusion and Ischemic preconditioning and intravenous lactate in people with Metabolic Syndrome and Vascular Injury, run by Gary Van Guilder at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Vascular Injury, Ischemic Preconditioning
- What is being tested?
- Ischemic preconditioning, Intravenous lactate infusion and Ischemic preconditioning and intravenous lactate
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 30 Jun 2030
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Use of medications known to affect cardiovascular function
- Hyperlactemia
- Type A lactic acidosis
- Type B lactic acidosis
- Extracellular hyperhydration or hypervolemia
- Hyperkaliemia
Show all 25Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
High Altitude Physiology Laboratory at Western Colorado University
Gunnison, Colorado, 81231
Gary P Van Guilder, PhD, 970-943-7133, gvanguilder@western.edu
About this study
Official title: Therapeutic Strategies to Reduce Endothelial Ischemia-reperfusion Injury with Metabolic Syndrome: a Combination Approach with Lactate Administration and Ischemic Preconditioning
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:
Read more
- Does giving lactate intravenously reduce injury to the vascular system?
- Does giving lactate intravenously together with blood flow occlusion - known as ischemic preconditioning, reduce vascular injury better than blood flow occlusion by itself?
- 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.
Read the detailed description
Much of the mortality burden of ischemic heart disease is due to untreatable complications of ischemia-reperfusion (I/R) injury, greatly undermining the translation of cardioprotective interventions. Endothelial damage and dysfunction are centrally involved in many of the clinical consequences of myocardial I/R injury. While a very promising therapeutic defense mechanism against I/R-induced endothelial dysfunction is ischemic preconditioning (IPC), it has not fared well in multi-center phase III clinical trials. Complementary strategies that elicit additive or synergistic benefits against I/R injury are urgently needed. Because lactate has extensive endothelial protective effects, the recruitment of additional protective pathways with lactate that cannot be activated with IPC alone provides an innovative and powerful strategy to greatly enhance cardioprotection in the clinical arena. Little is understood about whether including lactate with IPC as a dual approach can bolster protection in adults with CVD risk in which the endothelial protective effects of IPC are already weakened. The long-term goal of this research is to develop improved combination therapeutic strategies to expedite the clinical application of IPC for cardioprotective purposes. The objective is to better understand how lactate administration can be used to alleviate endothelial I/R injury. In a model of endothelial I/R injury, our central hypothesis is that lactate administration alone will reduce endothelial dysfunction, and when included as a combination strategy with IPC, will improve protection with metabolic syndrome. The rationale for the proposed research is based on the poor translatability of existing cardioprotective strategies to date. The central hypothesis will be tested by pursuing three aims: 1) Determine the degree to which lactate administration attenuates endothelial I/R injury; 2) Determine the superiority of a combined multi-targeted therapeutic strategy against endothelial I/R injury in adults with metabolic syndrome; and 3) Establish mechanistic insight into the endothelial protective effects of lactate. In Aim #1, the investigators will utilize a randomized equivalence trial comparing the effects of lactate administration versus IPC on endothelial function in 32 adults. For Aim #2, a randomized superiority trial in 36 adults with metabolic syndrome will compare the dual effects of IPC combined with lactate versus IPC alone. For Aim #3, a series of biomarker studies by which lactate is likely to modify the therapeutic response to I/R injury are proposed. For Aims #1 and #2, endothelium-dependent vasodilation (primary endpoint) will be compared between trials for equivalence, and superiority, respectively. For Aim #3, the investigators expect lactate will protect against endothelial I/R injury, in part, by reducing circulating microparticles of endothelial activation and vascular inflammation, and increasing total antioxidant capacity, nitric oxide bioavailability, and angiogenic factors. The approach is conceptually innovative because the findings are likely to be the first in vivo evidence supporting the development of a multi-faceted approach that exploits the potential for synergistic cytoprotection involving IPC combined with lactate. This contribution would advance the development of new translatable strategies for cardioprotection.
- Conditions
- Metabolic Syndrome, Vascular Injury, Ischemic Preconditioning, Endothelial Function (reactive Hyperemia), Endothelial Dysfunction
- Being tested
- Ischemic preconditioning, Intravenous lactate infusion, No ischemic preconditioning (control), Normal Saline Infusion (Placebo), Ischemic preconditioning and intravenous lactate
- Keywords
- endothelial ischemia/reperfusion injury, remote ischemic preconditioning, lactate, metabolic syndrome
- Medical subject headings
- Metabolic Syndrome, Vascular System Injuries, Hyperemia, Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemic preconditioningProcedure or surgery
The objective of this Intervention is to show that ischemic preconditioning (IPC) protects against endothelial ischemia/reperfusion injury. Baseline endothelium-dependent vasodilation to reactive hyperemia will be performed on the nondominant arm, followed by 3 × 5-minute cycles of IPC in the opposite arm. IPC will be induced using a blood pressure cuff placed on the opposite upper arm and inflated to 220 mmHg for 5 min, followed by 5 min of deflation. This procedure will be repeated two additional times taking about 30 minutest to complete. Following a 10-minute rest phase, endothelial injury will be induced using a blood pressure cuff that will be inflated to stop blood flow through the nondominant arm for 20 minutes, followed by 15 minutes of cuff deflation. Endothelium-dependent vasodilation measurements will be repeated immediately after the 15-minute cuff deflation phase.
Intravenous lactate infusionDrug
The objective of this Intervention is to show that an intravenous infusion of lactate protects against endothelial ischemia/reperfusion injury. Baseline endothelium-dependent vasodilation to reactive hyperemia will be performed on the nondominant arm. Thereafter, a continuous intravenous infusion of lactate will be delivered in the contralateral arm. After systemic lactate reaches ~3 mmol/L, endothelial injury will be induced using a blood pressure cuff that will be inflated to stop blood flow through the nondominant arm for 20 minutes, followed by 15 minutes of cuff deflation. Endothelium-dependent vasodilation measurements will be repeated immediately after the 15-minute cuff deflation phase.
No ischemic preconditioning (control)Procedure or surgery
The objective of this Intervention is to show that a control experiment without ischemic preconditioning does not provide protection against endothelial ischemia/reperfusion injury. Baseline endothelium-dependent vasodilation to reactive hyperemia will be performed on the nondominant arm, followed by 3 × 5-minute cycles of no upper arm occlusion in the opposite arm. To avoid upper arm occlusion, a blood pressure cuff will be placed on the upper arm and inflated to a low pressure of 20 mmHg pressure to not influence blood flow through the arm. This control procedure will be repeated two additional times taking about 30 minutes to complete. Following a 10-minute rest phase, endothelial injury will be induced using a blood pressure cuff that will be inflated to stop blood flow through the nondominant arm for 20 minutes, followed by 15 minutes of cuff deflation. Endothelium-dependent vasodilation measurements will be repeated immediately after the 15-minute cuff deflation phase.
Normal Saline Infusion (Placebo)Drug
The objective of this Intervention is to show that a placebo intravenous infusion does not protect against endothelial ischemia/reperfusion injury. Baseline endothelium-dependent vasodilation to reactive hyperemia will be performed on the nondominant arm. Thereafter, a continuous infusion of normal saline that does not contain lactate will be delivered in the contralateral arm. After 20 minutes of the placebo infusion, endothelial injury will be induced using a blood pressure cuff that will be inflated to stop blood flow through the nondominant arm for 20 minutes, followed by 15 minutes of cuff deflation. Endothelium-dependent vasodilation measurements will be repeated immediately after the 15-minute cuff deflation phase.
Ischemic preconditioning and intravenous lactateCombination product
The objective of this Intervention is to show that combining ischemic preconditioning (IPC) with an intravenous infusion of lactate provides the best protection against endothelial injury. First, baseline endothelial function to reactive hyperemia will be performed on the nondominant arm. Thereafter, a continuous intravenous infusion of lactate will be delivered in the contralateral arm. After that investigators will administer IPC using a blood pressure cuff placed on the same upper arm and inflated to 220 mmHg for 5 min, followed by 5 min of deflation. This procedure will be repeated two more times taking about 30 minutes to complete. The intravenous lactate infusion will be maintained. After a 10-minute rest phase and while lactate is still being infused, endothelial injury will be induced using a blood pressure cuff inflated to stop blood flow through the opposite arm (nondominant arm) for 20 minutes, followed by 15 minutes of cuff deflation. Endothelial function will be repeated.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic preconditioning versus intravenous lactate infusion | Active comparator | 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. Receives: Procedure: Ischemic preconditioning; Drug: Intravenous lactate infusion; Procedure: No ischemic preconditioning (control); Drug: Normal Saline Infusion (Placebo) |
| Ischemic preconditioning combined with an intravenous lactate infusion | Experimental | 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. Receives: Procedure: Ischemic preconditioning; Combination Product: Ischemic preconditioning and intravenous lactate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline value of the mean peak forearm blood flow response to reactive hyperemia.
Endothelium-dependent vasodilation will be assessed in the experimental (nondominant) arm by the forearm blood flow response to reactive hyperemia using strain-gauge venous occlusion plethysmography. Data are reported in ml of blood per 100 mL arm volume per minute.
Measured: Baseline (time 0)
Mean peak forearm blood flow response to reactive hyperemia at 3 hours.
Endothelium-dependent vasodilation will be assessed in the experimental (nondominant) arm by the forearm blood flow response to reactive hyperemia using strain-gauge venous occlusion plethysmography. Data are reported in ml of blood per 100 mL arm volume per minute.
Measured: At 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start1 Oct 2026 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The overall interventional study model will utilize a parallel design equivalence trial and a parallel design superiority trial. Both trials will have two Arms.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gary Van Guilder
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gary Van Guilder, Western Colorado University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825143
- Sponsor's protocol ID
- HRC-2024-02-06-R33
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Strategies to Reduce Endothelial Ischemia-reperfusion Injury with Metabolic Syndrome: a Combination Approach with Lactate Administration and Ischemic Preconditioning
- ClinicalTrials.gov ID
- NCT06825143
- Acronym / sponsor ID
- HRC-2024-02-06-R33
- Conditions
- Metabolic Syndrome, Vascular Injury, Ischemic Preconditioning, Endothelial Function (reactive Hyperemia), Endothelial Dysfunction
- Keywords
- endothelial ischemia/reperfusion injury, remote ischemic preconditioning, lactate, metabolic syndrome
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Gary Van GuilderUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does giving lactate intravenously reduce injury to the vascular system?
- Does giving lactate intravenously together with blood flow occlusion - known as ischemic preconditioning, reduce vascular injury better than blood flow occlusion by itself?
- 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.
Detailed description
Much of the mortality burden of ischemic heart disease is due to untreatable complications of ischemia-reperfusion (I/R) injury, greatly undermining the translation of cardioprotective interventions. Endothelial damage and dysfunction are centrally involved in many of the clinical consequences of myocardial I/R injury. While a very promising therapeutic defense mechanism against I/R-induced endothelial dysfunction is ischemic preconditioning (IPC), it has not fared well in multi-center phase III clinical trials. Complementary strategies that elicit additive or synergistic benefits against I/R injury are urgently needed. Because lactate has extensive endothelial protective effects, the recruitment of additional protective pathways with lactate that cannot be activated with IPC alone provides an innovative and powerful strategy to greatly enhance cardioprotection in the clinical arena. Little is understood about whether including lactate with IPC as a dual approach can bolster protection in adults with CVD risk in which the endothelial protective effects of IPC are already weakened. The long-term goal of this research is to develop improved combination therapeutic strategies to expedite the clinical application of IPC for cardioprotective purposes. The objective is to better understand how lactate administration can be used to alleviate endothelial I/R injury. In a model of endothelial I/R injury, our central hypothesis is that lactate administration alone will reduce endothelial dysfunction, and when included as a combination strategy with IPC, will improve protection with metabolic syndrome. The rationale for the proposed research is based on the poor translatability of existing cardioprotective strategies to date. The central hypothesis will be tested by pursuing three aims: 1) Determine the degree to which lactate administration attenuates endothelial I/R injury; 2) Determine the superiority of a combined multi-targeted therapeutic strategy against endothelial I/R injury in adults with metabolic syndrome; and 3) Establish mechanistic insight into the endothelial protective effects of lactate. In Aim #1, the investigators will utilize a randomized equivalence trial comparing the effects of lactate administration versus IPC on endothelial function in 32 adults. For Aim #2, a randomized superiority trial in 36 adults with metabolic syndrome will compare the dual effects of IPC combined with lactate versus IPC alone. For Aim #3, a series of biomarker studies by which lactate is likely to modify the therapeutic response to I/R injury are proposed. For Aims #1 and #2, endothelium-dependent vasodilation (primary endpoint) will be compared between trials for equivalence, and superiority, respectively. For Aim #3, the investigators expect lactate will protect against endothelial I/R injury, in part, by reducing circulating microparticles of endothelial activation and vascular inflammation, and increasing total antioxidant capacity, nitric oxide bioavailability, and angiogenic factors. The approach is conceptually innovative because the findings are likely to be the first in vivo evidence supporting the development of a multi-faceted approach that exploits the potential for synergistic cytoprotection involving IPC combined with lactate. This contribution would advance the development of new translatable strategies for cardioprotection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The overall interventional study model will utilize a parallel design equivalence trial and a parallel design superiority trial. Both trials will have two Arms.
| Arm | Type | Receives |
|---|---|---|
| Ischemic preconditioning versus intravenous lactate infusion | Active comparator | Procedure: Ischemic preconditioning, Drug: Intravenous lactate infusion, Procedure: No ischemic preconditioning (control), Drug: Normal Saline Infusion (Placebo)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. |
| Ischemic preconditioning combined with an intravenous lactate infusion | Experimental | Procedure: Ischemic preconditioning, Combination Product: Ischemic preconditioning and intravenous lactateTo 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (25 listed)
- Use of medications known to affect cardiovascular function
- Hyperlactemia
- Type A lactic acidosis
- Type B lactic acidosis
- Extracellular hyperhydration or hypervolemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ischemic preconditioningThe objective of this Intervention is to show that ischemic preconditioning (IPC) protects against endothelial ischemia/reperfusion injury. Baseline endothelium-dependent vasodilation to reactive hyperemia will be performed on the nondominant arm, followed by 3 × 5-minute cycles of IPC in the opposite arm. IPC will be induced using a blood pressure cuff placed on the opposite upper arm and inflated to 220 mmHg for 5 min, followed by 5 min of deflation. This procedure will be repeated two additional times taking about 30 minutest to complete. Following a 10-minute rest phase, endothelial injury will be induced using a blood pressure cuff that will be inflated to stop blood flow through the nondominant arm for 20 minutes, followed by 15 minutes of cuff deflation. Endothelium-dependent vasodilation measurements will be repeated immediately after the 15-minute cuff deflation phase. | Procedure or surgery | Ischemic preconditioning combined with an intravenous lactate infusion, Ischemic preconditioning versus intravenous lactate infusion |
| Intravenous lactate infusionThe objective of this Intervention is to show that an intravenous infusion of lactate protects against endothelial ischemia/reperfusion injury. Baseline endothelium-dependent vasodilation to reactive hyperemia will be performed on the nondominant arm. Thereafter, a continuous intravenous infusion of lactate will be delivered in the contralateral arm. After systemic lactate reaches ~3 mmol/L, endothelial injury will be induced using a blood pressure cuff that will be inflated to stop blood flow through the nondominant arm for 20 minutes, followed by 15 minutes of cuff deflation. Endothelium-dependent vasodilation measurements will be repeated immediately after the 15-minute cuff deflation phase. | Drug | Ischemic preconditioning versus intravenous lactate infusion |
| No ischemic preconditioning (control)The objective of this Intervention is to show that a control experiment without ischemic preconditioning does not provide protection against endothelial ischemia/reperfusion injury. Baseline endothelium-dependent vasodilation to reactive hyperemia will be performed on the nondominant arm, followed by 3 × 5-minute cycles of no upper arm occlusion in the opposite arm. To avoid upper arm occlusion, a blood pressure cuff will be placed on the upper arm and inflated to a low pressure of 20 mmHg pressure to not influence blood flow through the arm. This control procedure will be repeated two additional times taking about 30 minutes to complete. Following a 10-minute rest phase, endothelial injury will be induced using a blood pressure cuff that will be inflated to stop blood flow through the nondominant arm for 20 minutes, followed by 15 minutes of cuff deflation. Endothelium-dependent vasodilation measurements will be repeated immediately after the 15-minute cuff deflation phase. | Procedure or surgery | Ischemic preconditioning versus intravenous lactate infusion |
| Normal Saline Infusion (Placebo)The objective of this Intervention is to show that a placebo intravenous infusion does not protect against endothelial ischemia/reperfusion injury. Baseline endothelium-dependent vasodilation to reactive hyperemia will be performed on the nondominant arm. Thereafter, a continuous infusion of normal saline that does not contain lactate will be delivered in the contralateral arm. After 20 minutes of the placebo infusion, endothelial injury will be induced using a blood pressure cuff that will be inflated to stop blood flow through the nondominant arm for 20 minutes, followed by 15 minutes of cuff deflation. Endothelium-dependent vasodilation measurements will be repeated immediately after the 15-minute cuff deflation phase. | Drug | Ischemic preconditioning versus intravenous lactate infusion |
| Ischemic preconditioning and intravenous lactateThe objective of this Intervention is to show that combining ischemic preconditioning (IPC) with an intravenous infusion of lactate provides the best protection against endothelial injury. First, baseline endothelial function to reactive hyperemia will be performed on the nondominant arm. Thereafter, a continuous intravenous infusion of lactate will be delivered in the contralateral arm. After that investigators will administer IPC using a blood pressure cuff placed on the same upper arm and inflated to 220 mmHg for 5 min, followed by 5 min of deflation. This procedure will be repeated two more times taking about 30 minutes to complete. The intravenous lactate infusion will be maintained. After a 10-minute rest phase and while lactate is still being infused, endothelial injury will be induced using a blood pressure cuff inflated to stop blood flow through the opposite arm (nondominant arm) for 20 minutes, followed by 15 minutes of cuff deflation. Endothelial function will be repeated. | Combination product | Ischemic preconditioning combined with an intravenous lactate infusion |
Primary outcome
Baseline value of the mean peak forearm blood flow response to reactive hyperemia.
Time frame: Baseline (time 0)
Endothelium-dependent vasodilation will be assessed in the experimental (nondominant) arm by the forearm blood flow response to reactive hyperemia using strain-gauge venous occlusion plethysmography. Data are reported in ml of blood per 100 mL arm volume per minute.
Mean peak forearm blood flow response to reactive hyperemia at 3 hours.
Time frame: At 3 hours
Endothelium-dependent vasodilation will be assessed in the experimental (nondominant) arm by the forearm blood flow response to reactive hyperemia using strain-gauge venous occlusion plethysmography. Data are reported in ml of blood per 100 mL arm volume per minute.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ischemic preconditioning, Intravenous lactate infusion and Ischemic preconditioning and intravenous lactate in people with Metabolic Syndrome and Vascular Injury, run by Gary Van Guilder at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gary P Van Guilder, PhD (970-943-7133, gvanguilder@western.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline value of the mean peak forearm blood flow response to reactive hyperemia. (time frame: Baseline (time 0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.