Role of Elevated Lactate Levels on Lipid and Carbohydrate Metabolism. (LACTMET)

February 15, 2026 updated by: Ricardo Mora
The purpose of this study is to investigate whether the elevated circulating lactate levels of individuals with metabolic syndrome are responsible for their reduced lipolysis and glucose tolerance. The investigators will conduct an intervention study in which blood lactate levels will be elevated via intravenous infusion of sodium lactate. State of the art metabolic assessment using stable isotopes and indirect calorimetry will be used to study alterations in fat and carbohydrate metabolism.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Individuals with metabolic syndrome and insulin resistance exhibit higher resting lactate concentrations than age-matched counterparts without metabolic disease. Recent studies suggest that lactate is not just a by-product of accelerated glycolysis but a signaling molecule that could even affect gene expression. However, the role of lactate in carbohydrate and fat metabolism at rest and during exercise remains incompletely described.

In this study, the investigators will elevate blood lactate levels in metabolically healthy individuals to levels observed in individuals with metabolic syndrome while measuring fat and carbohydrate metabolism in a fasted state, during exercise, and in response to an oral glucose load (oral glucose tolerance test).

10 metabolically healthy (MH) and 10 metabolically impaired (MI) individuals matched for sex and physical activity will participate in the study. MH will undergo two trials: one with intravenous lactate infusion and the other with isovolumetric saline infusion. The MI group will undergo only the saline trial.

Each trial consists of a 150 min basal period, an exercise period, followed by a 2-hour oral glucose tolerance test (OGTT). During the test, the investigators will:

Measure insulin sensitivity during the OGTT (Matsuda Index). Measure fat and carbohydrate oxidation using indirect calorimetry. Use stable isotope infusion to measure glycerol and glucose turnover rates in plasma using [1,1,2,3,3 2H]-glycerol and [6-6 2H], [U, 13C] - glucose.

Collect blood samples of relevant hormones, metabolites, and cytokines.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Jesus Garcia-Pallares, PhD
  • Phone Number: +34665505278
  • Email: jgpallares@um.es

Study Locations

  • Spain
    • Murcia
      • San Javier, Murcia, Spain, 30720
        • Recruiting
        • Facultad de Ciencias del Deporte
        • Contact:
        • Sub-Investigator:
          • Jesus Garcia Pallares, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Men and women
  • >18 years of age
  • Women non-pregnant or taking contraceptive medication
  • Physically active according to WHO's guidelines
  • Metabolic syndrome as IDF 2009 criteria (Alberti et al., Circulation)
  • Written and verbal consent to participation

Exclusion Criteria:

  • Chronic illness that prevents them from exercising
  • Affected blood samples at screening, as assessed by the PI
  • Assessed as unsuitable by PI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Metabolically Healthy Individuals
Other: hyperlactacidemia
Raise blood lactate in metabolically healthy individuals to the levels of individuals with metabolic syndrome
Other: Saline (0.9%, sterile, for infusion)
Saline infusion as a control treatment
Active Comparator: Metabolic Syndrome Individuals
Other: Saline (0.9%, sterile, for infusion)
Saline infusion as a control treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lipolysis rate at rest, exercise and OGTT when blood lactate is elevated in MH individuals
Time Frame: through study completion, an average of 2 years
Change in plasma [1,1,2,3,3 D] glycerol turnover rates
through study completion, an average of 2 years
Effect of Na-Lactate on glucose tolerance to an oral load
Time Frame: through study completion, an average of 2 years
Change in plasma [6,6 D]-glucose turnover rate
through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin sensitivity
Time Frame: through study completion, an average of 2 years
The difference between groups and interventions in Matsuda ISI during the glucose tolerance test
through study completion, an average of 2 years
Indirect calorimetry
Time Frame: through study completion, an average of 2 years
Changes in fat and carbohydrate oxidation during treatments in both groups.
through study completion, an average of 2 years
Blood sample-insulin
Time Frame: through study completion, an average of 2 years
Insulin concentrations. Difference between interventions and groups
through study completion, an average of 2 years
Blood samples - glucose
Time Frame: through study completion, an average of 2 years
Glucose concentrations. Difference between interventions and groups
through study completion, an average of 2 years
Blood samples - Free fatty acids
Time Frame: through study completion, an average of 2 years
Free fatty acids concentration. Difference between interventions and groups
through study completion, an average of 2 years
Blood samples - Glycerol
Time Frame: through study completion, an average of 2 years
Glycerol concentrations. Difference between interventions and groups
through study completion, an average of 2 years
Blood samples - Lactate
Time Frame: through study completion, an average of 2 years
lactate concentrations. Difference between interventions and groups
through study completion, an average of 2 years
Blood tracer/tracee ratio of 13C/12C glucose
Time Frame: through study completion, an average of 2 years
Tracer/tracee ratio measured by CGMS of 13C/12C glucose
through study completion, an average of 2 years
13CO2 / 12CO2 in expired air
Time Frame: through study completion, an average of 2 years
Analisys of 13CO2 / 12CO2 by IRMS
through study completion, an average of 2 years
Blood tracer to tracee ratio of D2 glucose / unlabeled glucose
Time Frame: through study completion, an average of 2 years
Ratio of plasma D2 glucose / unlabeled glucose measured by GCMS
through study completion, an average of 2 years
Blood tracer to tracee ratio of D5 glycerol / unlabeled glycerol
Time Frame: through study completion, an average of 2 years
Blood ratio of D5 glycerol / unlabeled glycerol measured with GCMS
through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ricardo Mora

Collaborators

University of Castilla-La Mancha

Investigators

  • Principal Investigator: Ricardo Mora Rodriguez, PhD, University of Castilla-La Mancha
  • Principal Investigator: Jesus Garcia-Pallares, PhD, Universidad de Murcia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2026

Primary Completion (Estimated)

January 30, 2028

Study Completion (Estimated)

September 30, 2028

Study Registration Dates

First Submitted

February 8, 2026

First Submitted That Met QC Criteria

February 15, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 15, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPSP2025LACT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

it will be shared upon request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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