HealthyNCT06665763
The Lactate Project: Investigating the Impact of Lactate to Preserve Vital Organ Blood Supply and Function in Heart and Brain
A study testing Sodium Lactate Solution in people with Healthy and Lactate Blood Increase, run by University of Aarhus at 2 sites in Denmark.
Trial summary
The aim of the proposed study is to investigate the effect of increased plasma lactate concentrations on the heart and brain's metabolism of other energy sources, primarily glucose in the brain and glucose and FFA in the heart. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Lactate Blood Increase
- What is being tested?
- Sodium Lactate Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Feb 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 55-75 years
- Male or postmenopausal female
- BMI 20-35 kg/m2
- Signed informed consent form
Who cannot join
- Clinically significant heart, lung, kidney, kidney, liver, endocrine or malignant disease basedon information obtained during an initial screening visit as well as blood samples and an ECG.
- Blood donation within the last 3 months
- Smoking
- Alcohol- or substance abuse
- Participation in other clinical trials involving ionized radiation within the last 6 months
- Claustrophobia
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Medical Research Laboratories/Steno Diabetes Center Aarhus
Aarhus, N, 8000
Esben Søndergaard, MD, PhD, 0028 73 09 43, Esben.sondergaard@clin.au.dk
Jens Hohwü Voigt, MD, 0026395294, Jens.voigt@clin.au.dk
Department of Nuclear Medicine & PET-Centre
Aarhus, N, 8200
Lars Christian Gormsen, MD, PhD, Proffessor, 0022 81 16 31, lars.christian.gormsen@clin.au.dk
Jens Hohwü Voigt, MD, 0026395294, Jens.voigt@clin.au.dk
About this study
The aim of the proposed study is to investigate the effect of increased plasma lactate concentrations on the heart and brain's metabolism of other energy sources, primarily glucose in the brain and glucose and FFA in the heart.
The investigator hypothesize that:
- An acute increase in lactate plasma concentration will decrease cerebral glucose uptake and increase cerebral blood flow
- An acute increase in lactate plasma concentration will decrease palmitate and glucose uptake in the myocardium, and increase myocardial perfusion
Read the detailed description
SCREENING VISIT
During the initial screening visit, the investigators will inform all potential volunteers about the project, and volunteers will have the chance to ask questions about participation in the project.
The investigators will register the following data
- Medical history to assess exclusion criteria
- Weight, height, BMI
- Standard medical examination including pulse, blood pressure and an ECG
After assessment of inclusion- and exclusion criteria remaining volunteers will be offered to participate in the project. The investigators will screen potential volunteers with the following blood samples: haemoglobin, HbA1c, glucose, cholesterol, triglyceride, TSH, creatinine, albumin, sodium, potassium, ALAT, ASAT, bilirubin and coagulation parameters.
Blood samples and randomization will not take place until volunteers have signed the informed consent form.
MAGNETIC RESONANCE IMAGING (MRI) SCAN
The investigators will perform a cerebral MRI for the purpose of anatomical localisation for alignment with the PET scans on the 1st and 2nd study day.
1st STUDY DAY:
The volunteers will arrive fasted (8 hours) at the Department of Nuclear Medicine \& PET-Centre at 7.30 a.m., where the subject will have an arterial catheter placed for arterial blood sampling during PET scans as well as two venous catheters for blood sampling and continued administration of intravenous fluids (saline or Na-lactate) and adenosine. At 9.00 a.m., we will start the Na-lactate or saline infusion.
From 9.30 a.m., the investigators will perform PET scans with administration of relevant PET tracers preceding each scan. The investigators will perform PET scans in the following order:
- Dynamic PET scan with [15O]H2O in order to assess cerebral perfusion.
- Dynamic PET scan with [15O]H2O in order to assess myocardial perfusion.
- Stress test using an adenosine infusion during a dynamic PET scan with [15O]H2O to assess coronary flow reserve (CFR) in the heart.
- Dynamic PET scan with [11C]Palmitate to assess uptake, oxidation and re-esterification of FFA in the heart.
- Dynamic PET scan with [11C]Acetate to asses oxygen and energy expenditure in the heart.
- Dynamic whole-body PET scan with [18F]FDG to assess glucose uptake in the heart and brain.
Following the [11C]Acetate scan the investigators will administrate a continued infusion of insulin (0,3 mIE/kg/min) and 20% glucose throughout the rest of the study day in order to achieve hyperinsulinemic-euglycemic conditions (clamp conditions). To correct for attenuation, we will perform three lowdose, non-contrast enhanced CT scans over the course of the study day. The investigators will draw blood samples every hour.
2nd STUDY DAY
The PET scan regime during the 2nd study day is identical to the 1st study day. If volunteers were administered Na-lactate during the 1st study day they will be administered saline during the 2nd studyday and vice versa.
- Conditions
- Healthy, Lactate Blood Increase
- Being tested
- Sodium Lactate Solution, Saline infusion (placebo)
- Keywords
- Human metabolism, Substrate utilization, Cerebral blod flow, Cardiac metabolism, Cerebral metabolism, Cardiac perfusion, Glucose metabolism, Lipid metabolism, Lactate utilization
- Medical subject headings
- Hyperlactatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Lactate SolutionOther
Infusion of sodium-lactate solution
Saline infusion (placebo)Other
Also called NaCl
NaCl solution
| Study group | Role | What they receive |
|---|---|---|
| Na-Lactate infusion | Experimental | Not described Receives: Other: Sodium Lactate Solution |
| Saline infusion (Placebo) | Placebo comparator | Not described Receives: Other: Saline infusion (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral glucose uptake
Cerebral glucose uptake ([18F]FDG PET scan) under basal and hyperinsulinemic- euglycemic conditions (clamp conditions).
Measured: From T=300-360 (minutes)
Secondary outcomes (7)
Cerebral blood flow
Cerebral blood flow ([15O]H2O PET scan)
Measured: T = 0-10 (minutes)
Myocardial perfusion
Myocardial perfusion ([15O]H2O PET scan)
Measured: T = 0-10 (minutes)
Myocardial glucose uptake
Myocardial glucose uptake ([18F]FDG PET scan)
Measured: T = 300-360 (minutes)
Myocardial FFA uptake and oxidation
Myocardial FFA uptake and oxidation ([11C]Palmitate PET scan)
Measured: T = 30-70 (minutes)
Myocardial contractility
Myocardial contractility (ejection fraction based on ECG-gated PET scan)
Measured: T=0-10 (minutes)
Myocardial oxygen consumption and efficiency
Myocardial oxygen consumption and efficiency ([11C]Acetate PET scan)
Measured: T=150-180 (minutes)
Blood sampling
A number of cardiometabolic blood samples will be collected during the whole study day.
Measured: T = -60 to 360 (minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start1 Feb 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study will be carried out as a single-blinded, randomized cross-over clinical investigational trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665763
- Sponsor's protocol ID
- THE LACTATE PROJECT
- Status last verified
- Oct 2024
- First submitted
- 29 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Lactate Project: Investigating the Impact of Lactate to Preserve Vital Organ Blood Supply and Function in Heart and Brain
- ClinicalTrials.gov ID
- NCT06665763
- Acronym / sponsor ID
- THE LACTATE PROJECT
- Conditions
- Healthy, Lactate Blood Increase
- Keywords
- Human metabolism, Substrate utilization, Cerebral blod flow, Cardiac metabolism, Cerebral metabolism, Cardiac perfusion, Glucose metabolism, Lipid metabolism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 30 Oct 2024 (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 aim of the proposed study is to investigate the effect of increased plasma lactate concentrations on the heart and brain's metabolism of other energy sources, primarily glucose in the brain and glucose and FFA in the heart.
The investigator hypothesize that:
- An acute increase in lactate plasma concentration will decrease cerebral glucose uptake and increase cerebral blood flow
- An acute increase in lactate plasma concentration will decrease palmitate and glucose uptake in the myocardium, and increase myocardial perfusion
Detailed description
SCREENING VISIT
During the initial screening visit, the investigators will inform all potential volunteers about the project, and volunteers will have the chance to ask questions about participation in the project.
The investigators will register the following data
- Medical history to assess exclusion criteria
- Weight, height, BMI
- Standard medical examination including pulse, blood pressure and an ECG
After assessment of inclusion- and exclusion criteria remaining volunteers will be offered to participate in the project. The investigators will screen potential volunteers with the following blood samples: haemoglobin, HbA1c, glucose, cholesterol, triglyceride, TSH, creatinine, albumin, sodium, potassium, ALAT, ASAT, bilirubin and coagulation parameters.
Blood samples and randomization will not take place until volunteers have signed the informed consent form.
MAGNETIC RESONANCE IMAGING (MRI) SCAN
The investigators will perform a cerebral MRI for the purpose of anatomical localisation for alignment with the PET scans on the 1st and 2nd study day.
1st STUDY DAY:
The volunteers will arrive fasted (8 hours) at the Department of Nuclear Medicine \& PET-Centre at 7.30 a.m., where the subject will have an arterial catheter placed for arterial blood sampling during PET scans as well as two venous catheters for blood sampling and continued administration of intravenous fluids (saline or Na-lactate) and adenosine. At 9.00 a.m., we will start the Na-lactate or saline infusion.
From 9.30 a.m., the investigators will perform PET scans with administration of relevant PET tracers preceding each scan. The investigators will perform PET scans in the following order:
- Dynamic PET scan with [15O]H2O in order to assess cerebral perfusion.
- Dynamic PET scan with [15O]H2O in order to assess myocardial perfusion.
- Stress test using an adenosine infusion during a dynamic PET scan with [15O]H2O to assess coronary flow reserve (CFR) in the heart.
- Dynamic PET scan with [11C]Palmitate to assess uptake, oxidation and re-esterification of FFA in the heart.
- Dynamic PET scan with [11C]Acetate to asses oxygen and energy expenditure in the heart.
- Dynamic whole-body PET scan with [18F]FDG to assess glucose uptake in the heart and brain.
Following the [11C]Acetate scan the investigators will administrate a continued infusion of insulin (0,3 mIE/kg/min) and 20% glucose throughout the rest of the study day in order to achieve hyperinsulinemic-euglycemic conditions (clamp conditions). To correct for attenuation, we will perform three lowdose, non-contrast enhanced CT scans over the course of the study day. The investigators will draw blood samples every hour.
2nd STUDY DAY
The PET scan regime during the 2nd study day is identical to the 1st study day. If volunteers were administered Na-lactate during the 1st study day they will be administered saline during the 2nd studyday and vice versa.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study will be carried out as a single-blinded, randomized cross-over clinical investigational trial.
| Arm | Type | Receives |
|---|---|---|
| Na-Lactate infusion | Experimental | Other: Sodium Lactate Solution |
| Saline infusion (Placebo) | Placebo comparator | Other: Saline infusion (placebo) |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 55-75 years
- Male or postmenopausal female
- BMI 20-35 kg/m2
- Signed informed consent form
Key exclusion criteria (6 listed)
- Clinically significant heart, lung, kidney, kidney, liver, endocrine or malignant disease basedon information obtained during an initial screening visit as well as blood samples and an ECG.
- Blood donation within the last 3 months
- Smoking
- Alcohol- or substance abuse
- Participation in other clinical trials involving ionized radiation within the last 6 months
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 |
|---|---|---|
| Sodium Lactate SolutionInfusion of sodium-lactate solution | Other | Na-Lactate infusion |
| Saline infusion (placebo)Also: NaClNaCl solution | Other | Saline infusion (Placebo) |
Primary outcome
Cerebral glucose uptake
Time frame: From T=300-360 (minutes)
Cerebral glucose uptake ([18F]FDG PET scan) under basal and hyperinsulinemic- euglycemic conditions (clamp conditions).
7 secondary outcomes
Cerebral blood flow
Time frame: T = 0-10 (minutes)
Myocardial perfusion
Time frame: T = 0-10 (minutes)
Myocardial glucose uptake
Time frame: T = 300-360 (minutes)
Myocardial FFA uptake and oxidation
Time frame: T = 30-70 (minutes)
Myocardial contractility
Time frame: T=0-10 (minutes)
Myocardial oxygen consumption and efficiency
Time frame: T=150-180 (minutes)
Blood sampling
Time frame: T = -60 to 360 (minutes)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- 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. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Lactate Solution in people with Healthy and Lactate Blood Increase, run by University of Aarhus at 2 sites in Denmark.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esben Søndergaard, MD, PhD (004528730943, Esben.sondergaard@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral glucose uptake (time frame: From T=300-360 (minutes)). 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 1 Nov 2024.