An interventional study of Sodium Lactate Solution and Saline infusion (placebo) in Healthy and Lactate Blood Increase, sponsored by University of Aarhus. Not yet recruiting at 2 sites in Denmark. Open to participants aged 55 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-01.
Sponsored by University of Aarhus · Not applicable, Interventional, and Basic science
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:
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
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:
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.
50 studies on the registry are indexed under Hyperlactatemia; 7 are open to participants now.
This study's planned enrollment of 8 is below the median of 38 across 32 interventional studies indexed under Hyperlactatemia.
Browse Hyperlactatemia studies →University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Sodium Lactate Solution
Other: Saline infusion (placebo)
Infusion of sodium-lactate solution
NaCl solution
Also known as: NaCl
Cerebral glucose uptake
Cerebral glucose uptake (\[18F\]FDG PET scan) under basal and hyperinsulinemic- euglycemic conditions (clamp conditions).
Time frame: From T=300-360 (minutes)
Cerebral blood flow
Cerebral blood flow (\[15O\]H2O PET scan)
Time frame: T = 0-10 (minutes)
Myocardial perfusion
Myocardial perfusion (\[15O\]H2O PET scan)
Time frame: T = 0-10 (minutes)
Myocardial glucose uptake
Myocardial glucose uptake (\[18F\]FDG PET scan)
Time frame: T = 300-360 (minutes)
Myocardial FFA uptake and oxidation
Myocardial FFA uptake and oxidation (\[11C\]Palmitate PET scan)
Time frame: T = 30-70 (minutes)
Myocardial contractility
Myocardial contractility (ejection fraction based on ECG-gated PET scan)
Time frame: T=0-10 (minutes)
Myocardial oxygen consumption and efficiency
Myocardial oxygen consumption and efficiency (\[11C\]Acetate PET scan)
Time frame: T=150-180 (minutes)
Blood sampling
A number of cardiometabolic blood samples will be collected during the whole study day.
Time frame: T = -60 to 360 (minutes)
Plan to share: No
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This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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