HyperlactatemiaLILACHNCT04710875
The Role of Lactate in Lipolysis and Catabolism in Humans
A study testing Na-lactate and Sodium chloride in people with Hyperlactatemia and Healthy, run by University of Aarhus at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperlactatemia, Healthy, Lactate
- What is being tested?
- Na-lactate and Sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 2 sitesDenmark
- Study dates
- 10 Mar 2021to 29 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male
- >18 years of age
- BMI >19 and below 30
- Written and verbal consent to participation
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Medical/Steno Aarhus research laboratory
Aarhus, Central Region Denmark, 8200
Aarhus University Hospital
Aarhus N, 8200
About this study
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.
Read more
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.
- Conditions
- Hyperlactatemia, Healthy, Lactate
- Being tested
- Na-lactate, Sodium chloride
- Keywords
- Lipolysis, Catabolism, Glucose metabolism, Aminoacid metabolisme
- Medical subject headings
- Hyperlactatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Na-lactateDrug
Also called Sodium lactate
intravenous
Sodium chlorideDrug
Also called NaCl
Intravenous
| Study group | Role | What they receive |
|---|---|---|
| Na-lactate | Active comparator | Iv infusion of sodium D/L lactate Receives: Drug: Na-lactate |
| Sodium chloride | Placebo comparator | Iv infusion of Sodium chloride Receives: Drug: Sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Metabolic effects of Na-lactate compared with NaCl on lipolysis
Change in [9,10-3H]-palmitate tracer flux
Measured: 2 hours (1 hour basal period, 1 hour clamp)
Secondary outcomes (19)
Acute Metabolic effects of Na-lactate compared with NaCl on glucose metabolism
Change in glucose metabolism quantified with [3-3H]-glucose tracer
Measured: 6 hours (3 hours basal period, 3 hours clamp)
Insulin sensitivity
Hyperinsulinaemic euglycaemic clamp with 0.6mU/kg/min insulin and 20% glucose to calculate M value. Difference between interventions.
Measured: 3 hours.
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.
Measured: 6 hours
Indirect calorimetry during clamp
Change in estimation of resting energy expenditure during clamp. Difference between interventions.
Measured: 20 minutes
Indirect calorimetry during basal conditions
Change in estimation of respiratory quotient during basal period. Difference between interventions.
Measured: 20 minutes
Echocardiography
Change in cardiac ejection fraction during basal period. Difference between interventions.
Measured: 15 minutes
Echocardiography
Change in cardiac ejection fraction during clamp period. Difference between interventions.
Measured: 15 minutes
blood pressure
blood pressure (systolic and diastolic) during basal- and clamp
Measured: 2 x 10 min
Blood samples - Insulin
Insulin concentrations. Difference between interventions.
Measured: 6 hours.
Blood samples - c-peptid
c-peptid concentrations. Difference between interventions.
Measured: 6 hours.
Blood samples - glucagon
glucagon concentrations. Difference between interventions.
Measured: 6 hours.
Blood samples - cortisol
cortisol concentrations. Difference between interventions.
Measured: 6 hours.
Blood samples - Ghrelin
Ghrelin concentrations. Difference between interventions.
Measured: 6 hours.
Blood samples - GDF-15
GDF-15 concentrations. Difference between interventions.
Measured: 6 hours.
Blood samples - free fatte acids
Free fatte acids concentrations. Difference between interventions.
Measured: 6 hours.
Blood samples - glucose
glucose concentrations. Difference between interventions.
Measured: 6 hours.
Blood samples - lactate
lactate concentrations. Difference between interventions.
Measured: 6 hours.
Changes in signaling in muscle tissue between interventions
Western blot examinations of muscle tissue biopsies
Measured: After 3 and 5 hours of intervention
Changes in signaling in adipose tissue between interventions
Western blot examinations of adipose tissue biopsies
Measured: After 3 and 5 hours of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start10 Mar 2021
- Primary completion29 Jun 2021
- Study completion29 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperlactatemiaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Niels Møller, Prof, MD, DMSc, Study director, Medical/Steno Aarhus research laboratory, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710875
- Sponsor's protocol ID
- 1-10-72.180-20
- Acronym
- LILACH
- Status last verified
- Sep 2020
- First submitted
- 1 Dec 2020
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39825426
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Lactate in Lipolysis and Catabolism in Humans
- ClinicalTrials.gov ID
- NCT04710875
- Acronym / sponsor ID
- LILACH / 1-10-72.180-20
- Conditions
- Hyperlactatemia, Healthy, Lactate
- Keywords
- Lipolysis, Catabolism, Glucose metabolism, Aminoacid metabolisme
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 29 Jun 2021 (actual)
- Study completion
- 29 Jun 2021 (actual)
- First posted
- 15 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Na-lactate | Active comparator | Drug: Na-lactateIv infusion of sodium D/L lactate |
| Sodium chloride | Placebo comparator | Drug: Sodium chlorideIv infusion of Sodium chloride |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male
- >18 years of age
- BMI >19 and below 30
- Written and verbal consent to participation
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Na-lactateAlso: Sodium lactateintravenous | Drug | Na-lactate |
| Sodium chlorideAlso: NaClIntravenous | Drug | Sodium chloride |
Primary outcome
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
19 secondary outcomes
Acute Metabolic effects of Na-lactate compared with NaCl on glucose metabolism
Time frame: 6 hours (3 hours basal period, 3 hours clamp)
Insulin sensitivity
Time frame: 3 hours.
Acute metabolic effects of Na-lactate compared with NaCl on aminoacid metabolism
Time frame: 6 hours
Indirect calorimetry during clamp
Time frame: 20 minutes
Indirect calorimetry during basal conditions
Time frame: 20 minutes
Echocardiography
Time frame: 15 minutes
Echocardiography
Time frame: 15 minutes
blood pressure
Time frame: 2 x 10 min
Blood samples - Insulin
Time frame: 6 hours.
Blood samples - c-peptid
Time frame: 6 hours.
Blood samples - glucagon
Time frame: 6 hours.
Blood samples - cortisol
Time frame: 6 hours.
Blood samples - Ghrelin
Time frame: 6 hours.
Blood samples - GDF-15
Time frame: 6 hours.
Blood samples - free fatte acids
Time frame: 6 hours.
Blood samples - glucose
Time frame: 6 hours.
Blood samples - lactate
Time frame: 6 hours.
Changes in signaling in muscle tissue between interventions
Time frame: After 3 and 5 hours of intervention
Changes in signaling in adipose tissue between interventions
Time frame: After 3 and 5 hours of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Derived from this study: PubMed 39825426Berg-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels Møller, Prof, MD, DMSc study director
Medical/Steno Aarhus research laboratory, Aarhus University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Na-lactate and Sodium chloride in people with Hyperlactatemia and Healthy, run by University of Aarhus at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Metabolic effects of Na-lactate compared with NaCl on lipolysis (time frame: 2 hours (1 hour basal period, 1 hour clamp)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04710875, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.