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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

Tracking Information
First Submitted Date  ICMJE December 1, 2020
First Posted Date  ICMJE January 15, 2021
Last Update Posted Date January 15, 2021
Estimated Study Start Date  ICMJE February 1, 2021
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2021)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2021)
  • 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
  • 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.
  • 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.
  • Indirect calorimetry during clamp [ Time Frame: 20 minutes ]
    Change in estimation of resting energy expenditure during clamp. Difference between interventions.
  • Indirect calorimetry during basal conditions [ Time Frame: 20 minutes ]
    Change in estimation of respiratory quotient during basal period. Difference between interventions.
  • Echocardiography [ Time Frame: 15 minutes ]
    Change in cardiac ejection fraction during basal period. Difference between interventions.
  • Echocardiography [ Time Frame: 15 minutes ]
    Change in cardiac ejection fraction during clamp period. Difference between interventions.
  • blood pressure [ Time Frame: 2 x 10 min ]
    blood pressure (systolic and diastolic) during basal- and clamp
  • Blood samples - Insulin [ Time Frame: 6 hours. ]
    Insulin concentrations. Difference between interventions.
  • Blood samples - c-peptid [ Time Frame: 6 hours. ]
    c-peptid concentrations. Difference between interventions.
  • Blood samples - glucagon [ Time Frame: 6 hours. ]
    glucagon concentrations. Difference between interventions.
  • Blood samples - cortisol [ Time Frame: 6 hours. ]
    cortisol concentrations. Difference between interventions.
  • Blood samples - Ghrelin [ Time Frame: 6 hours. ]
    Ghrelin concentrations. Difference between interventions.
  • Blood samples - GDF-15 [ Time Frame: 6 hours. ]
    GDF-15 concentrations. Difference between interventions.
  • Blood samples - free fatte acids [ Time Frame: 6 hours. ]
    Free fatte acids concentrations. Difference between interventions.
  • Blood samples - glucose [ Time Frame: 6 hours. ]
    glucose concentrations. Difference between interventions.
  • Blood samples - lactate [ Time Frame: 6 hours. ]
    lactate concentrations. Difference between interventions.
  • Changes in signaling in muscle tissue between interventions [ Time Frame: After 3 and 5 hours of intervention ]
    Western blot examinations of muscle tissue biopsies
  • Changes in signaling in adipose tissue between interventions [ Time Frame: After 3 and 5 hours of intervention ]
    Western blot examinations of adipose tissue biopsies
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Role of Lactate in Lipolysis and Catabolism in Humans
Official Title  ICMJE The Role of Lactate in Lipolysis and Catabolism in Humans
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE
  • Hyperlactatemia
  • Healthy
  • Lactate
Intervention  ICMJE
  • Drug: Na-lactate
    intravenous
    Other Name: Sodium lactate
  • Drug: Sodium chloride
    Intravenous
    Other Name: NaCl
Study Arms  ICMJE
  • Active Comparator: Na-lactate
    Iv infusion of sodium D/L lactate
    Intervention: Drug: Na-lactate
  • Placebo Comparator: Sodium chloride
    Iv infusion of Sodium chloride
    Intervention: Drug: Sodium chloride
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 12, 2021)
8
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2021
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Mette GB Pedersen, MD 40857288 metteglavind@clin.au.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04710875
Other Study ID Numbers  ICMJE 1-10-72.180-20
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Aarhus
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Niels Møller, Prof, MD, DMSc Medical/Steno Aarhus research laboratory, Aarhus University Hospital
PRS Account University of Aarhus
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP