NCT04710875: LILACH

The Role of Lactate in Lipolysis and Catabolism in Humans

Completed NA Last updated 24 January 2022

What this trial tests

NA trial testing Na-lactate in Hyperlactatemia in 8 participants. Completed in 29 June 2021.

Timeline

10 March 2021

Primary endpoint
29 June 2021

29 June 2021

Quick facts

Lead sponsor	University of Aarhus
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	other
Enrollment	8
Start date	10 March 2021
Primary completion	29 June 2021
Estimated completion	29 June 2021
Sites	2 locations across Denmark

Drugs / interventions tested

• Na-lactate — full drug profile →
• Sodium chloride (Sodium Chloride) — full drug profile →

Conditions studied

• Hyperlactatemia — all drugs for Hyperlactatemia →
• Healthy — all drugs for Healthy →
• Lactate — all drugs for Lactate →

Sponsor

University of Aarhus

Who can join

18 and older, male only, with Hyperlactatemia or Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cardiovascular effects of lactate in healthy adults.
   Berg-Hansen K, Gopalasingam N, Pedersen MGB, Nyvad JT, et al · · 2025 · cited 10× · PMID 39825426 · DOI 10.1186/s13054-025-05259-0
2. Effects of exogenous lactate on lipid, protein, and glucose metabolism-a randomized crossover trial in healthy males.
   Pedersen MGB, Rittig N, Bangshaab M, Berg-Hansen K, et al · · 2024 · cited 7× · PMID 38324259 · DOI 10.1152/ajpendo.00301.2023