The Role of Lactate in Lipolysis and Catabolism in Humans

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-10

Study Completion Date

2021-06-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Lactate in the Gut

NCT04299815

Lactate Healthy Hyperlactatemia

COMPLETED NA

Study of the Metabolism of Pyruvate and Related Problems in Patients With Lactic Acidemia

NCT00004353

Mitochondrial Myopathy MELAS Syndrome Lactic Acidosis

COMPLETED

Pharmacotoxicology of Trichloroethylene Metabolites

NCT00874276

Congenital Lactic Acidosis

COMPLETED NA

Weight-Adjusted Dosing of 3-OHB in Patients With Chronic Heart Failure

NCT04594265

Heart Failure Ketosis

UNKNOWN PHASE2

Human Heterologous Liver Cells for Infusion in Children With Urea Cycle Disorders

NCT00718627

Urea Cycle Disorders Carbamoylphosphate Synthetase I Deficiency Ornithine Transcarbamylase Deficiency +1 more

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperlactatemia Healthy Lactate

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Na-lactate

Iv infusion of sodium D/L lactate

Group Type ACTIVE_COMPARATOR

Na-lactate

Intervention Type DRUG

intravenous

Sodium chloride

Iv infusion of Sodium chloride

Group Type PLACEBO_COMPARATOR

Sodium chloride

Intervention Type DRUG

Intravenous

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Na-lactate

intravenous

Intervention Type DRUG

Sodium chloride

Intravenous

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Sodium lactate NaCl

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes