NCT04710875

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:

  • 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

March 10, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2021

Completed
Last Updated

January 24, 2022

Status Verified

September 1, 2020

Enrollment Period

4 months

First QC Date

December 1, 2020

Last Update Submit

January 21, 2022

Conditions

HyperlactatemiaHealthyLactate

Keywords

LipolysisCatabolismGlucose metabolismAminoacid metabolisme

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (19)

  • Acute Metabolic effects of Na-lactate compared with NaCl on glucose metabolism

    6 hours (3 hours basal period, 3 hours clamp)

  • Insulin sensitivity

    3 hours.

  • Acute metabolic effects of Na-lactate compared with NaCl on aminoacid metabolism

    6 hours

  • Indirect calorimetry during clamp

    20 minutes

  • Indirect calorimetry during basal conditions

    20 minutes

  • +14 more secondary outcomes

Study Arms (2)

Na-lactate

ACTIVE COMPARATOR

Iv infusion of sodium D/L lactate

Drug: Na-lactate

Sodium chloride

PLACEBO COMPARATOR

Iv infusion of Sodium chloride

Drug: Sodium chloride

Interventions

Na-lactateDRUG

intravenous

Also known as: Sodium lactate
Na-lactate
Sodium chlorideDRUG

Intravenous

Also known as: NaCl
Sodium chloride

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical/Steno Aarhus research laboratory

Aarhus, Central Region Denmark, 8200, Denmark

Location

Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

Related Publications (1)

  • Berg-Hansen K, Gopalasingam N, Pedersen MGB, Nyvad JT, Rittig N, Sondergaard E, Wiggers H, Moller N, Nielsen R. Cardiovascular effects of lactate in healthy adults. Crit Care. 2025 Jan 17;29(1):30. doi: 10.1186/s13054-025-05259-0.

    PMID: 39825426DERIVED

MeSH Terms

Conditions

Hyperlactatemia

Interventions

Sodium LactateSodium Chloride

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LactatesHydroxy AcidsCarboxylic AcidsOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Niels Møller, Prof, MD, DMSc

    Medical/Steno Aarhus research laboratory, Aarhus University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2020

First Posted

January 15, 2021

Study Start

March 10, 2021

Primary Completion

June 29, 2021

Study Completion

June 29, 2021

Last Updated

January 24, 2022

Record last verified: 2020-09

Locations

DK(2)