An interventional study of Oral Sodium Lactate and Intravenous sodium lactate in Lactate, Healthy and Hyperlactatemia, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-30.
Sponsored by University of Aarhus · Not applicable, Interventional, and Other
Lactate is formed naturally in the body in example during physical activity. However, lactate is also formed during food fermentation where certain bacterial strains form lactate. Lactate can also be produced chemically. An example of this is Ringer-lactate which is used for volume replacement when treating dehydrated patients.
As a source of carbon-molecules, lactate is believed to be an important oxidative fuel source in all major organs and yields adenosine triphosphate (ATP) production through Krebs cycle, the Electron Transport Chain in the mitochondria as well as by being a key precursor for gluconeogenesis.
Metformin is the first drug of choice for type 2 diabetes treatment. Use of metformin often results in a small but significant weight loss in overweight users. It is known that metformin increases the lactate concentration in the gut. It is also known also know that metformin use is associated with an increase in blood concentrations of growth differentiation factor 15 (GDF-15). Receptors for GDF-15 can be found in parts of the brain associated with control of appetite. In rats increases in [GDF-15] results in a decrease in appetite and thus weight loss. GDF-15 is thought to be involved in the normal energy homeostasis.
With this study the investigators want to examine the hormonal, metabolic and mechanical effects of lactate in the gut in healthy volunteers. Our hypothesis is that lactate has beneficial effects which may be though an increase in GDF-15 in the blood.
Volunteers will undergo two study days separated by at least 7 days and a maximum of 1 month.
50 studies on the registry are indexed under Hyperlactatemia; 7 are open to participants now.
This study's enrollment of 10 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.
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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.
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.
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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.
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.
Sodium D/L lactate solution, 25g/L in 300mL water
Drug: Oral Sodium Lactate
iv sodium D/L lactate to elevate \[lactate\] to the same levels as measured on day 1 + oral sodium chloride, 300 mL
Drug: Intravenous sodium lactate
25 grams of D/L lactate dissolved in 300mL water.
intravenous sodium lactate + oral sodium-chlorid solution
GDF-15
Difference in \[GDF-15\] between intervention and placebo
Time frame: 4 hours
glucagon-like peptide -1
Difference in \[glucagon-like peptide -1\] between intervention and placebo
Time frame: 4 hours
Gastric inhibitory peptide (GIP)
Difference in plasma \[GIP\] between intervention and placebo
Time frame: 4 hours
free fatty acid
Difference in \[free fatty acid \] between intervention and placebo
Time frame: 4 hours
cholecystokinin
Difference in \[cholecystokinin\] between intervention and placebo
Time frame: 4 hours
Ghrelin
Difference in \[Ghrelin\] between intervention and placebo
Time frame: 4 hours
Gastrin
Difference in \[Gastrin\] between intervention and placebo
Time frame: 4 hours
C-peptide
Difference in \[C-peptide\] between intervention and placebo
Time frame: 4 hours
glucose
Difference in \[glucose\] between intervention and placebo
Time frame: 4 hours
gastric emptying
\[Paracetamol\] to asses gastric emptying
Time frame: 4 hours
Evaluation of hunger
Evaluation of hunger, thoughts of future food intake ect using a questionnaire
Time frame: 4 hours
Ran from Apr 2020 to primary completion in Jul 2020, 3 months.
Of 17 interventional studies with no phase under Hyperlactatemia, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 12. This study's 3 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sodium Lactate