The Role of Lactate in Lipolysis and Catabolism in Humans (LILACH)
Primary Purpose
Hyperlactatemia, Healthy, Lactate
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Na-lactate
Sodium chloride
Sponsored by
About this trial
This is an interventional other trial for Hyperlactatemia focused on measuring Lipolysis, Catabolism, Glucose metabolism, Aminoacid metabolisme
Eligibility 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.
Sites / Locations
- Medical/Steno Aarhus research laboratory
- Aarhus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Na-lactate
Sodium chloride
Arm Description
Iv infusion of sodium D/L lactate
Iv infusion of Sodium chloride
Outcomes
Primary Outcome Measures
Acute Metabolic effects of Na-lactate compared with NaCl on lipolysis
Change in [9,10-3H]-palmitate tracer flux
Secondary Outcome Measures
Acute Metabolic effects of Na-lactate compared with NaCl on glucose metabolism
Change in glucose metabolism quantified with [3-3H]-glucose tracer
Insulin sensitivity
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
Change in aminoacid metabolism quantified with [15N]-phenylalanine, [15N]tyrosine, [2H4]tyrosine and [13C]-Urea tracers.
Indirect calorimetry during clamp
Change in estimation of resting energy expenditure during clamp. Difference between interventions.
Indirect calorimetry during basal conditions
Change in estimation of respiratory quotient during basal period. Difference between interventions.
Echocardiography
Change in cardiac ejection fraction during basal period. Difference between interventions.
Echocardiography
Change in cardiac ejection fraction during clamp period. Difference between interventions.
blood pressure
blood pressure (systolic and diastolic) during basal- and clamp
Blood samples - Insulin
Insulin concentrations. Difference between interventions.
Blood samples - c-peptid
c-peptid concentrations. Difference between interventions.
Blood samples - glucagon
glucagon concentrations. Difference between interventions.
Blood samples - cortisol
cortisol concentrations. Difference between interventions.
Blood samples - Ghrelin
Ghrelin concentrations. Difference between interventions.
Blood samples - GDF-15
GDF-15 concentrations. Difference between interventions.
Blood samples - free fatte acids
Free fatte acids concentrations. Difference between interventions.
Blood samples - glucose
glucose concentrations. Difference between interventions.
Blood samples - lactate
lactate concentrations. Difference between interventions.
Changes in signaling in muscle tissue between interventions
Western blot examinations of muscle tissue biopsies
Changes in signaling in adipose tissue between interventions
Western blot examinations of adipose tissue biopsies
Full Information
NCT ID
NCT04710875
First Posted
December 1, 2020
Last Updated
January 21, 2022
Sponsor
University of Aarhus
1. Study Identification
Unique Protocol Identification Number
NCT04710875
Brief Title
The Role of Lactate in Lipolysis and Catabolism in Humans
Acronym
LILACH
Official Title
The Role of Lactate in Lipolysis and Catabolism in Humans
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 10, 2021 (Actual)
Primary Completion Date
June 29, 2021 (Actual)
Study Completion Date
June 29, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
Intravenous sodium D/L-lactate
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlactatemia, Healthy, Lactate
Keywords
Lipolysis, Catabolism, Glucose metabolism, Aminoacid metabolisme
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Na-lactate
Arm Type
Active Comparator
Arm Description
Iv infusion of sodium D/L lactate
Arm Title
Sodium chloride
Arm Type
Placebo Comparator
Arm Description
Iv infusion of Sodium chloride
Intervention Type
Drug
Intervention Name(s)
Na-lactate
Other Intervention Name(s)
Sodium lactate
Intervention Description
intravenous
Intervention Type
Drug
Intervention Name(s)
Sodium chloride
Other Intervention Name(s)
NaCl
Intervention Description
Intravenous
Primary Outcome Measure Information:
Title
Acute Metabolic effects of Na-lactate compared with NaCl on lipolysis
Description
Change in [9,10-3H]-palmitate tracer flux
Time Frame
2 hours (1 hour basal period, 1 hour clamp)
Secondary Outcome Measure Information:
Title
Acute Metabolic effects of Na-lactate compared with NaCl on glucose metabolism
Description
Change in glucose metabolism quantified with [3-3H]-glucose tracer
Time Frame
6 hours (3 hours basal period, 3 hours clamp)
Title
Insulin sensitivity
Description
Hyperinsulinaemic euglycaemic clamp with 0.6mU/kg/min insulin and 20% glucose to calculate M value. Difference between interventions.
Time Frame
3 hours.
Title
Acute metabolic effects of Na-lactate compared with NaCl on aminoacid metabolism
Description
Change in aminoacid metabolism quantified with [15N]-phenylalanine, [15N]tyrosine, [2H4]tyrosine and [13C]-Urea tracers.
Time Frame
6 hours
Title
Indirect calorimetry during clamp
Description
Change in estimation of resting energy expenditure during clamp. Difference between interventions.
Time Frame
20 minutes
Title
Indirect calorimetry during basal conditions
Description
Change in estimation of respiratory quotient during basal period. Difference between interventions.
Time Frame
20 minutes
Title
Echocardiography
Description
Change in cardiac ejection fraction during basal period. Difference between interventions.
Time Frame
15 minutes
Title
Echocardiography
Description
Change in cardiac ejection fraction during clamp period. Difference between interventions.
Time Frame
15 minutes
Title
blood pressure
Description
blood pressure (systolic and diastolic) during basal- and clamp
Time Frame
2 x 10 min
Title
Blood samples - Insulin
Description
Insulin concentrations. Difference between interventions.
Time Frame
6 hours.
Title
Blood samples - c-peptid
Description
c-peptid concentrations. Difference between interventions.
Time Frame
6 hours.
Title
Blood samples - glucagon
Description
glucagon concentrations. Difference between interventions.
Time Frame
6 hours.
Title
Blood samples - cortisol
Description
cortisol concentrations. Difference between interventions.
Time Frame
6 hours.
Title
Blood samples - Ghrelin
Description
Ghrelin concentrations. Difference between interventions.
Time Frame
6 hours.
Title
Blood samples - GDF-15
Description
GDF-15 concentrations. Difference between interventions.
Time Frame
6 hours.
Title
Blood samples - free fatte acids
Description
Free fatte acids concentrations. Difference between interventions.
Time Frame
6 hours.
Title
Blood samples - glucose
Description
glucose concentrations. Difference between interventions.
Time Frame
6 hours.
Title
Blood samples - lactate
Description
lactate concentrations. Difference between interventions.
Time Frame
6 hours.
Title
Changes in signaling in muscle tissue between interventions
Description
Western blot examinations of muscle tissue biopsies
Time Frame
After 3 and 5 hours of intervention
Title
Changes in signaling in adipose tissue between interventions
Description
Western blot examinations of adipose tissue biopsies
Time Frame
After 3 and 5 hours of intervention
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels Møller, Prof, MD, DMSc
Organizational Affiliation
Medical/Steno Aarhus research laboratory, Aarhus University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Medical/Steno Aarhus research laboratory
City
Aarhus
State/Province
Central Region Denmark
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Aarhus University Hospital
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
12. IPD Sharing Statement
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The Role of Lactate in Lipolysis and Catabolism in Humans
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