An interventional study of Na-lactate and Sodium chloride in Hyperlactatemia, Healthy and Lactate, sponsored by University of Aarhus. Completed at 2 sites in Denmark. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-24.
Sponsored by University of Aarhus · Not applicable, Interventional, and Other
Lactate may have anti-lipolytic effects when plasma concentrations of lactate reach levels similar to those seen during high intensity exercise.
This study aims to investigate how lactate concentrations similar to those achieved during high intensity exercise affects lipolysis in humans. In addition to this, to investigate how increased lactate concentrations affects glucose- and amino acid metabolism.
8 healthy males will be included. Study participants will undergo two separate investigation days that will be identical except for the interventions:
The study consists of a 3-hour basal period followed by a 3-hour hyperinsulinemic euglycemic clamp. During the study we will:
50 studies on the registry are indexed under Hyperlactatemia; 7 are open to participants now.
This study's 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.
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.
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.
Iv infusion of sodium D/L lactate
Drug: Na-lactate
Iv infusion of Sodium chloride
Drug: Sodium chloride
intravenous
Also known as: Sodium lactate
Intravenous
Also known as: NaCl
Acute Metabolic effects of Na-lactate compared with NaCl on lipolysis
Change in \[9,10-3H\]-palmitate tracer flux
Time frame: 2 hours (1 hour basal period, 1 hour clamp)
Acute Metabolic effects of Na-lactate compared with NaCl on glucose metabolism
Change in glucose metabolism quantified with \[3-3H\]-glucose tracer
Time frame: 6 hours (3 hours basal period, 3 hours clamp)
Insulin sensitivity
Hyperinsulinaemic euglycaemic clamp with 0.6mU/kg/min insulin and 20% glucose to calculate M value. Difference between interventions.
Time frame: 3 hours.
Acute metabolic effects of Na-lactate compared with NaCl on aminoacid metabolism
Change in aminoacid metabolism quantified with \[15N\]-phenylalanine, \[15N\]tyrosine, \[2H4\]tyrosine and \[13C\]-Urea tracers.
Time frame: 6 hours
Indirect calorimetry during clamp
Change in estimation of resting energy expenditure during clamp. Difference between interventions.
Time frame: 20 minutes
Indirect calorimetry during basal conditions
Change in estimation of respiratory quotient during basal period. Difference between interventions.
Time frame: 20 minutes
Echocardiography
Change in cardiac ejection fraction during basal period. Difference between interventions.
Time frame: 15 minutes
Echocardiography
Change in cardiac ejection fraction during clamp period. Difference between interventions.
Time frame: 15 minutes
blood pressure
blood pressure (systolic and diastolic) during basal- and clamp
Time frame: 2 x 10 min
Blood samples - Insulin
Insulin concentrations. Difference between interventions.
Time frame: 6 hours.
Blood samples - c-peptid
c-peptid concentrations. Difference between interventions.
Time frame: 6 hours.
Blood samples - glucagon
glucagon concentrations. Difference between interventions.
Time frame: 6 hours.
Blood samples - cortisol
cortisol concentrations. Difference between interventions.
Time frame: 6 hours.
Blood samples - Ghrelin
Ghrelin concentrations. Difference between interventions.
Time frame: 6 hours.
Blood samples - GDF-15
GDF-15 concentrations. Difference between interventions.
Time frame: 6 hours.
Blood samples - free fatte acids
Free fatte acids concentrations. Difference between interventions.
Time frame: 6 hours.
Blood samples - glucose
glucose concentrations. Difference between interventions.
Time frame: 6 hours.
Blood samples - lactate
lactate concentrations. Difference between interventions.
Time frame: 6 hours.
Changes in signaling in muscle tissue between interventions
Western blot examinations of muscle tissue biopsies
Time frame: After 3 and 5 hours of intervention
Changes in signaling in adipose tissue between interventions
Western blot examinations of adipose tissue biopsies
Time frame: After 3 and 5 hours of intervention
Ran from Mar 2021 to primary completion in Jun 2021, 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 Sep 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