The Lactate Project: Investigating the Impact of Lactate to Preserve Vital Organ Blood Supply and Function in Heart and Brain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sodium Lactate Solution, Saline infusion (placebo).
- Who it may be relevant to
- Registry conditions: Healthy, Lactate Blood Increase. Basic parameters: 55 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
1. Medical history to assess exclusion criteria 2. Weight, height, BMI 3. 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:
1. Dynamic PET scan with \[15O\]H2O in order to assess cerebral perfusion. 2. Dynamic PET scan with \[15O\]H2O in order to assess myocardial perfusion. 3. Stress test using an adenosine infusion during a dynamic PET scan with \[15O\]H2O to assess coronary flow reserve (CFR) in the heart. 4. Dynamic PET scan with \[11C\]Palmitate to assess uptake, oxidation and re-esterification of FFA in the heart. 5. Dynamic PET scan with \[11C\]Acetate to asses oxygen and energy expenditure in the heart. 6. 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.
Interventions
- Other Sodium Lactate Solution
Infusion of sodium-lactate solution - Other Saline infusion (placebo)
NaCl solution
Primary outcome measures
- Cerebral glucose uptake [Time frame: From T=300-360 (minutes)]
Secondary outcome measures (7)
- 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)]
Eligibility criteria
Inclusion criteria
- Age 55-75 years
- Male or postmenopausal female
- BMI 20-35 kg/m2
- Signed informed consent form
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
Denmark · 2 centers
- Medical Research Laboratories/Steno Diabetes Center Aarhus — Aarhus
- Department of Nuclear Medicine & PET-Centre — Aarhus
Identifiers
NCT: NCT06665763 · THE LACTATE PROJECT