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

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ClinicalTrials.gov Identifier: NCT04710875
Recruitment Status : Recruiting
First Posted : January 15, 2021
Last Update Posted : January 15, 2021
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

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:

  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.

Condition or disease Intervention/treatment Phase
Hyperlactatemia Healthy Lactate Drug: Na-lactate Drug: Sodium chloride Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: The Role of Lactate in Lipolysis and Catabolism in Humans
Estimated Study Start Date : February 1, 2021
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Na-lactate
Iv infusion of sodium D/L lactate
Drug: Na-lactate
intravenous
Other Name: Sodium lactate

Placebo Comparator: Sodium chloride
Iv infusion of Sodium chloride
Drug: Sodium chloride
Intravenous
Other Name: NaCl




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04710875


Contacts
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Contact: Mette GB Pedersen, MD 40857288 metteglavind@clin.au.dk

Locations
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Denmark
Medical/Steno Aarhus research laboratory Recruiting
Aarhus, Central Region Denmark, Denmark, 8200
Contact: Mette GB Pedersen, MD    40857288    metteglavind@clin.au.dk   
Principal Investigator: Mette GB Pedersen, MD         
Sub-Investigator: Niels Møller, MD, DMSc         
Sub-Investigator: Esben Søndergaard, MD, PhD         
Sub-Investigator: Lars C Gormsen, MD, PhD         
Sub-Investigator: Nikolaj Rittig, MD, PhD         
Aarhus University Hospital Recruiting
Aarhus N, Denmark, 8200
Contact: Mette GB Pedersen, MD         
Sponsors and Collaborators
University of Aarhus
Investigators
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Study Director: Niels Møller, Prof, MD, DMSc Medical/Steno Aarhus research laboratory, Aarhus University Hospital
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT04710875    
Other Study ID Numbers: 1-10-72.180-20
First Posted: January 15, 2021    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
Lipolysis
Catabolism
Glucose metabolism
Aminoacid metabolisme
Additional relevant MeSH terms:
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Hyperlactatemia
Metabolic Diseases