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The Role of Lactate in Lipolysis and Catabolism in Humans

The Role of Lactate in Lipolysis and Catabolism in Humans

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04710875
Acronym
LILACH
Enrollment
8
Registered
2021-01-15
Start date
2021-03-10
Completion date
2021-06-29
Last updated
2022-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Hyperlactatemia, Lactate

Keywords

Lipolysis, Catabolism, Glucose metabolism, Aminoacid metabolisme

Brief summary

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: 1. Intravenous sodium D/L-lactate 2. Intravenous sodium chloride. The study consists of a 3-hour basal period followed by a 3-hour hyperinsulinemic euglycemic clamp. During the study we will: * Estimate insulin sensitivity during the hyperinsulinemic euglycemic clamp (M value) * Use tracer kinetics to estimate lipid-, glucose and amino acid metabolism using \[9,10-3H\]-palmitate, \[3-3H\]-glucose, \[15N\]-phenylalanine, \[15N\]-tyrosine, \[2H4\]-tyrosine and \[13C\]-Urea. * Do muscle- and adipose tissue biopsies for analyses of signaling pathways involved in regulation of lipid-, glucose and amino acid metabolism. * Do blood samples of relevant hormones, metabolites and cytokines. * Use indirect calorimetry to estimate study participants' resting energy expenditure and respiratory quotient during the basal period. * Estimate cardiac ejection fraction by echocardiography and measure blood pressure during both the basal- and clamp period.

Interventions

DRUGNa-lactate

intravenous

DRUGSodium chloride

Intravenous

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* male * \>18 years of age * BMI \>19 and below 30 * Written and verbal consent to participation

Exclusion criteria

* Chronic illness * daily use of medicine * affected blood samples at screening, as assessed by the PI * does not speak and understand Danish * Assessed unsuitable by PI.

Design outcomes

Primary

MeasureTime frameDescription
Acute Metabolic effects of Na-lactate compared with NaCl on lipolysis2 hours (1 hour basal period, 1 hour clamp)Change in \[9,10-3H\]-palmitate tracer flux

Secondary

MeasureTime frameDescription
Acute Metabolic effects of Na-lactate compared with NaCl on glucose metabolism6 hours (3 hours basal period, 3 hours clamp)Change in glucose metabolism quantified with \[3-3H\]-glucose tracer
Insulin sensitivity3 hours.Hyperinsulinaemic euglycaemic clamp with 0.6mU/kg/min insulin and 20% glucose to calculate M value. Difference between interventions.
Acute metabolic effects of Na-lactate compared with NaCl on aminoacid metabolism6 hoursChange in aminoacid metabolism quantified with \[15N\]-phenylalanine, \[15N\]tyrosine, \[2H4\]tyrosine and \[13C\]-Urea tracers.
Indirect calorimetry during clamp20 minutesChange in estimation of resting energy expenditure during clamp. Difference between interventions.
Indirect calorimetry during basal conditions20 minutesChange in estimation of respiratory quotient during basal period. Difference between interventions.
Echocardiography15 minutesChange in cardiac ejection fraction during basal period. Difference between interventions.
blood pressure2 x 10 minblood pressure (systolic and diastolic) during basal- and clamp
Blood samples - Insulin6 hours.Insulin concentrations. Difference between interventions.
Changes in signaling in muscle tissue between interventionsAfter 3 and 5 hours of interventionWestern blot examinations of muscle tissue biopsies
Blood samples - glucagon6 hours.glucagon concentrations. Difference between interventions.
Blood samples - cortisol6 hours.cortisol concentrations. Difference between interventions.
Blood samples - Ghrelin6 hours.Ghrelin concentrations. Difference between interventions.
Blood samples - GDF-156 hours.GDF-15 concentrations. Difference between interventions.
Blood samples - free fatte acids6 hours.Free fatte acids concentrations. Difference between interventions.
Blood samples - glucose6 hours.glucose concentrations. Difference between interventions.
Blood samples - lactate6 hours.lactate concentrations. Difference between interventions.
Changes in signaling in adipose tissue between interventionsAfter 3 and 5 hours of interventionWestern blot examinations of adipose tissue biopsies
Blood samples - c-peptid6 hours.c-peptid concentrations. Difference between interventions.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026