The Role of Lactate in Lipolysis and Catabolism in Humans

Healthy Clinical Trial

— LILACH  

Official title:

The Role of Lactate in Lipolysis and Catabolism in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04710875
• Other study ID #: 1-10-72.180-20
• Status: Completed
• Phase: N/A
• Start date: March 10, 2021
• Est. completion date: June 29, 2021

Study information

• Verified date: September 2020
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 29, 2021
• Est. primary completion date: June 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Hyperlactatemia
• Lactate

Intervention

Drug:
• Na-lactate
intravenous
• Sodium chloride
Intravenous

Locations

Country	Name	City	State
Denmark	Medical/Steno Aarhus research laboratory	Aarhus	Central Region Denmark
Denmark	Aarhus University Hospital	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Metabolic effects of Na-lactate compared with NaCl on lipolysis	Change in [9,10-3H]-palmitate tracer flux	2 hours (1 hour basal period, 1 hour clamp)
Secondary	Acute Metabolic effects of Na-lactate compared with NaCl on glucose metabolism	Change in glucose metabolism quantified with [3-3H]-glucose tracer	6 hours (3 hours basal period, 3 hours clamp)
Secondary	Insulin sensitivity	Hyperinsulinaemic euglycaemic clamp with 0.6mU/kg/min insulin and 20% glucose to calculate M value. Difference between interventions.	3 hours.
Secondary	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.	6 hours
Secondary	Indirect calorimetry during clamp	Change in estimation of resting energy expenditure during clamp. Difference between interventions.	20 minutes
Secondary	Indirect calorimetry during basal conditions	Change in estimation of respiratory quotient during basal period. Difference between interventions.	20 minutes
Secondary	Echocardiography	Change in cardiac ejection fraction during basal period. Difference between interventions.	15 minutes
Secondary	Echocardiography	Change in cardiac ejection fraction during clamp period. Difference between interventions.	15 minutes
Secondary	blood pressure	blood pressure (systolic and diastolic) during basal- and clamp	2 x 10 min
Secondary	Blood samples - Insulin	Insulin concentrations. Difference between interventions.	6 hours.
Secondary	Blood samples - c-peptid	c-peptid concentrations. Difference between interventions.	6 hours.
Secondary	Blood samples - glucagon	glucagon concentrations. Difference between interventions.	6 hours.
Secondary	Blood samples - cortisol	cortisol concentrations. Difference between interventions.	6 hours.
Secondary	Blood samples - Ghrelin	Ghrelin concentrations. Difference between interventions.	6 hours.
Secondary	Blood samples - GDF-15	GDF-15 concentrations. Difference between interventions.	6 hours.
Secondary	Blood samples - free fatte acids	Free fatte acids concentrations. Difference between interventions.	6 hours.
Secondary	Blood samples - glucose	glucose concentrations. Difference between interventions.	6 hours.
Secondary	Blood samples - lactate	lactate concentrations. Difference between interventions.	6 hours.
Secondary	Changes in signaling in muscle tissue between interventions	Western blot examinations of muscle tissue biopsies	After 3 and 5 hours of intervention
Secondary	Changes in signaling in adipose tissue between interventions	Western blot examinations of adipose tissue biopsies	After 3 and 5 hours of intervention