Clinical trial NCT04710875: The Role of Lactate in Lipolysis and Catabolism in Humans
Official title: The Role of Lactate in Lipolysis and Catabolism in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlactatemia
Healthy
Lactate
Keywords: Lipolysis
Catabolism
Glucose metabolism
Aminoacid metabolisme
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Acute Metabolic effects of Na-lactate compared with NaCl on lipolysis
timeFrame: 2 hours (1 hour basal period, 1 hour clamp)
Secondary outcomes:
measure: Acute Metabolic effects of Na-lactate compared with NaCl on glucose metabolism
timeFrame: 6 hours (3 hours basal period, 3 hours clamp)
measure: Insulin sensitivity
timeFrame: 3 hours.
measure: Acute metabolic effects of Na-lactate compared with NaCl on aminoacid metabolism
timeFrame: 6 hours
measure: Indirect calorimetry during clamp
timeFrame: 20 minutes
measure: Indirect calorimetry during basal conditions
timeFrame: 20 minutes
measure: Echocardiography
timeFrame: 15 minutes
measure: Echocardiography
timeFrame: 15 minutes
measure: blood pressure
timeFrame: 2 x 10 min
measure: Blood samples - Insulin
timeFrame: 6 hours.
measure: Blood samples - c-peptid
timeFrame: 6 hours.
measure: Blood samples - glucagon
timeFrame: 6 hours.
measure: Blood samples - cortisol
timeFrame: 6 hours.
measure: Blood samples - Ghrelin
timeFrame: 6 hours.
measure: Blood samples - GDF-15
timeFrame: 6 hours.
measure: Blood samples - free fatte acids
timeFrame: 6 hours.
measure: Blood samples - glucose
timeFrame: 6 hours.
measure: Blood samples - lactate
timeFrame: 6 hours.
measure: Changes in signaling in muscle tissue between interventions
timeFrame: After 3 and 5 hours of intervention
measure: Changes in signaling in adipose tissue between interventions
timeFrame: After 3 and 5 hours of intervention
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Medical/Steno Aarhus research laboratory
state: Central Region Denmark
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Medical/Steno Aarhus research laboratory, Aarhus University Hospital
name: Niels Møller, Prof, MD, DMSc
role: STUDY_DIRECTOR
References: