The Role of Lactate in Lipolysis and Catabolism in Humans (LILACH)

University of Aarhus

Status: Completed

Conditions: Hyperlactatemia; Healthy; Lactate

Treatments: Drug: Sodium chloride; Drug: Na-lactate

Study type: Interventional

Funder types: Other

Identifiers

NCT04710875

1-10-72.180-20

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

8 participants in 2 patient groups, including a placebo group

Na-lactate

Active Comparator group

Description:

Iv infusion of sodium D/L lactate

Treatment:

Drug: Na-lactate

Sodium chloride

Placebo Comparator group

Description:

Iv infusion of Sodium chloride

Treatment:

Drug: Sodium chloride