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NCT Number: NCT04710875

The Role of Lactate in Lipolysis and Catabolism in Humans

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Medical/Steno Aarhus research laboratory, Aarhus, Central Region Denmark, Denmark

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Na-lactate

Drug

intravenous

Other names: Sodium lactate

Sodium Chloride

Drug

Intravenous

Other names: NaCl

Primary outcomes

  1. Acute Metabolic effects of Na-lactate compared with NaCl on lipolysis

    Time frame: 2 hours (1 hour basal period, 1 hour clamp)

    Change in [9,10-3H]-palmitate tracer flux

Secondary outcomes

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

    Time frame: 6 hours (3 hours basal period, 3 hours clamp)

    Change in glucose metabolism quantified with [3-3H]-glucose tracer

  2. Insulin sensitivity

    Time frame: 3 hours.

    Hyperinsulinaemic euglycaemic clamp with 0.6mU/kg/min insulin and 20% glucose to calculate M value. Difference between interventions.

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

    Time frame: 6 hours

    Change in aminoacid metabolism quantified with [15N]-phenylalanine, [15N]tyrosine, [2H4]tyrosine and [13C]-Urea tracers.

  4. Indirect calorimetry during clamp

    Time frame: 20 minutes

    Change in estimation of resting energy expenditure during clamp. Difference between interventions.

  5. Indirect calorimetry during basal conditions

    Time frame: 20 minutes

    Change in estimation of respiratory quotient during basal period. Difference between interventions.

  6. Echocardiography

    Time frame: 15 minutes

    Change in cardiac ejection fraction during basal period. Difference between interventions.

  7. Echocardiography

    Time frame: 15 minutes

    Change in cardiac ejection fraction during clamp period. Difference between interventions.

  8. blood pressure

    Time frame: 2 x 10 min

    blood pressure (systolic and diastolic) during basal- and clamp

  9. Blood samples - Insulin

    Time frame: 6 hours.

    Insulin concentrations. Difference between interventions.

  10. Blood samples - c-peptid

    Time frame: 6 hours.

    c-peptid concentrations. Difference between interventions.

  11. Blood samples - glucagon

    Time frame: 6 hours.

    glucagon concentrations. Difference between interventions.

  12. Blood samples - cortisol

    Time frame: 6 hours.

    cortisol concentrations. Difference between interventions.

  13. Blood samples - Ghrelin

    Time frame: 6 hours.

    Ghrelin concentrations. Difference between interventions.

  14. Blood samples - GDF-15

    Time frame: 6 hours.

    GDF-15 concentrations. Difference between interventions.

  15. Blood samples - free fatte acids

    Time frame: 6 hours.

    Free fatte acids concentrations. Difference between interventions.

  16. Blood samples - glucose

    Time frame: 6 hours.

    glucose concentrations. Difference between interventions.

  17. Blood samples - lactate

    Time frame: 6 hours.

    lactate concentrations. Difference between interventions.

  18. Changes in signaling in muscle tissue between interventions

    Time frame: After 3 and 5 hours of intervention

    Western blot examinations of muscle tissue biopsies

  19. Changes in signaling in adipose tissue between interventions

    Time frame: After 3 and 5 hours of intervention

    Western blot examinations of adipose tissue biopsies

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Acronym: LILACH

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 15, 2021
Registry last updated
Jan 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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