HyperlactatemiaLACTMETNCT07426172
Role of Elevated Lactate Levels on Lipid and Carbohydrate Metabolism.
A study testing hyperlactacidemia and Saline (0.9%, sterile, for infusion) in people with Hyperlactatemia and Metabolic Syndrome (MetS), run by Ricardo Mora at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlactatemia, Metabolic Syndrome (MetS), Lipolysis
- What is being tested?
- hyperlactacidemia and Saline (0.9%, sterile, for infusion)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jan 2026to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Chronic illness that prevents them from exercising
- Affected blood samples at screening, as assessed by the PI
- Assessed as unsuitable by PI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Facultad de Ciencias del Deporte
San Javier, Murcia, 30720
Jesus Garcia Pallares, PhD, +34665505278, jgpallares@um.es
Jesus Garcia Pallares, PhD
About this study
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.
Read the 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.
- Conditions
- Hyperlactatemia, Metabolic Syndrome (MetS), Lipolysis, Exercise
- Being tested
- hyperlactacidemia, Saline (0.9%, sterile, for infusion)
- Keywords
- blood lactate, lipolysis, oral glucose tolerance test, stable isotopes, indirect calorimetry, carbohydrate oxidation, fat oxidation, exercise, metabolic flexibility, metabolic syndrome
- Medical subject headings
- Hyperlactatemia, Metabolic Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperlactacidemiaOther
Raise blood lactate in metabolically healthy individuals to the levels of individuals with metabolic syndrome
Saline (0.9%, sterile, for infusion)Other
Saline infusion as a control treatment
| Study group | Role | What they receive |
|---|---|---|
| Metabolically Healthy Individuals | Placebo comparator | Metabolically Healthy Individuals Receives: Other: hyperlactacidemia; Other: Saline (0.9%, sterile, for infusion) |
| Metabolic Syndrome Individuals | Active comparator | Metabolic Syndrome Individuals Receives: Other: Saline (0.9%, sterile, for infusion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipolysis rate at rest, exercise and OGTT when blood lactate is elevated in MH individuals
Change in plasma [1,1,2,3,3 D] glycerol turnover rates
Measured: through study completion, an average of 2 years
Effect of Na-Lactate on glucose tolerance to an oral load
Change in plasma [6,6 D]-glucose turnover rate
Measured: through study completion, an average of 2 years
Secondary outcomes (11)
Insulin sensitivity
The difference between groups and interventions in Matsuda ISI during the glucose tolerance test
Measured: through study completion, an average of 2 years
Indirect calorimetry
Changes in fat and carbohydrate oxidation during treatments in both groups.
Measured: through study completion, an average of 2 years
Blood sample-insulin
Insulin concentrations. Difference between interventions and groups
Measured: through study completion, an average of 2 years
Blood samples - glucose
Glucose concentrations. Difference between interventions and groups
Measured: through study completion, an average of 2 years
Blood samples - Free fatty acids
Free fatty acids concentration. Difference between interventions and groups
Measured: through study completion, an average of 2 years
Blood samples - Glycerol
Glycerol concentrations. Difference between interventions and groups
Measured: through study completion, an average of 2 years
Blood samples - Lactate
lactate concentrations. Difference between interventions and groups
Measured: through study completion, an average of 2 years
Blood tracer/tracee ratio of 13C/12C glucose
Tracer/tracee ratio measured by CGMS of 13C/12C glucose
Measured: through study completion, an average of 2 years
13CO2 / 12CO2 in expired air
Analisys of 13CO2 / 12CO2 by IRMS
Measured: through study completion, an average of 2 years
Blood tracer to tracee ratio of D2 glucose / unlabeled glucose
Ratio of plasma D2 glucose / unlabeled glucose measured by GCMS
Measured: through study completion, an average of 2 years
Blood tracer to tracee ratio of D5 glycerol / unlabeled glycerol
Blood ratio of D5 glycerol / unlabeled glycerol measured with GCMS
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start20 Jan 2026
- Primary completion30 Jan 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HyperlactatemiaStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ricardo Mora
- Sponsor type
- University, hospital or other
- Collaborators
- University of Castilla-La Mancha
- Responsible party
- Sponsor-investigator, Ricardo Mora, University of Castilla-La Mancha
- Investigators
- Ricardo Mora Rodriguez, PhD, Principal investigator, University of Castilla-La ManchaJesus Garcia-Pallares, PhD, Principal investigator, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426172
- Sponsor's protocol ID
- EPSP2025LACT
- Acronym
- LACTMET
- Status last verified
- Feb 2026
- First submitted
- 8 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: it will be shared upon request
Publications
Emhoff CA, Messonnier LA, Horning MA, Fattor JA, Carlson TJ, Brooks GA. Direct and indirect lactate oxidation in trained and untrained men. J Appl Physiol (1985). 2013 Sep;115(6):829-38. doi: 10.1152/japplphysiol.00538.2013. Epub 2013 Jun 20.
PubMed 23788576Ahmed K, Tunaru S, Tang C, Muller M, Gille A, Sassmann A, Hanson J, Offermanns S. An autocrine lactate loop mediates insulin-dependent inhibition of lipolysis through GPR81. Cell Metab. 2010 Apr 7;11(4):311-9. doi: 10.1016/j.cmet.2010.02.012.
PubMed 20374963Pedersen MGB, Rittig N, Bangshaab M, Berg-Hansen K, Gopalasingam N, Gormsen LC, Sondergaard E, Moller N. Effects of exogenous lactate on lipid, protein, and glucose metabolism-a randomized crossover trial in healthy males. Am J Physiol Endocrinol Metab. 2024 Apr 1;326(4):E443-E453. doi: 10.1152/ajpendo.00301.2023. Epub 2024 Feb 7.
PubMed 38324259Ferrannini E, Natali A, Brandi LS, Bonadonna R, De Kreutzemberg SV, DelPrato S, Santoro D. Metabolic and thermogenic effects of lactate infusion in humans. Am J Physiol. 1993 Sep;265(3 Pt 1):E504-12. doi: 10.1152/ajpendo.1993.265.3.E504.
PubMed 8214058Jones TE, Pories WJ, Houmard JA, Tanner CJ, Zheng D, Zou K, Coen PM, Goodpaster BH, Kraus WE, Dohm GL. Plasma lactate as a marker of metabolic health: Implications of elevated lactate for impairment of aerobic metabolism in the metabolic syndrome. Surgery. 2019 Nov;166(5):861-866. doi: 10.1016/j.surg.2019.04.017. Epub 2019 Jun 25.
PubMed 31253418
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Elevated Lactate Levels on Lipid and Carbohydrate Metabolism.
- ClinicalTrials.gov ID
- NCT07426172
- Acronym / sponsor ID
- LACTMET / EPSP2025LACT
- Conditions
- Hyperlactatemia, Metabolic Syndrome (MetS), Lipolysis, Exercise
- Keywords
- blood lactate, lipolysis, oral glucose tolerance test, stable isotopes, indirect calorimetry, carbohydrate oxidation, fat oxidation, exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ricardo MoraUniversity, hospital or other
- Collaborators
- University of Castilla-La Mancha
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 30 Jan 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 23 Feb 2026 (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.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metabolically Healthy Individuals | Placebo comparator | Other: hyperlactacidemia, Other: Saline (0.9%, sterile, for infusion)Metabolically Healthy Individuals |
| Metabolic Syndrome Individuals | Active comparator | Other: Saline (0.9%, sterile, for infusion)Metabolic Syndrome Individuals |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (3 listed)
- Chronic illness that prevents them from exercising
- Affected blood samples at screening, as assessed by the PI
- Assessed as 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 |
|---|---|---|
| hyperlactacidemiaRaise blood lactate in metabolically healthy individuals to the levels of individuals with metabolic syndrome | Other | Metabolically Healthy Individuals |
| Saline (0.9%, sterile, for infusion)Saline infusion as a control treatment | Other | Metabolic Syndrome Individuals, Metabolically Healthy Individuals |
Primary outcome
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
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
11 secondary outcomes
Insulin sensitivity
Time frame: through study completion, an average of 2 years
Indirect calorimetry
Time frame: through study completion, an average of 2 years
Blood sample-insulin
Time frame: through study completion, an average of 2 years
Blood samples - glucose
Time frame: through study completion, an average of 2 years
Blood samples - Free fatty acids
Time frame: through study completion, an average of 2 years
Blood samples - Glycerol
Time frame: through study completion, an average of 2 years
Blood samples - Lactate
Time frame: 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
13CO2 / 12CO2 in expired air
Time frame: 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
Blood tracer to tracee ratio of D5 glycerol / unlabeled glycerol
Time frame: through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Background: PubMed 23788576Emhoff CA, Messonnier LA, Horning MA, Fattor JA, Carlson TJ, Brooks GA. Direct and indirect lactate oxidation in trained and untrained men. J Appl Physiol (1985). 2013 Sep;115(6):829-38. doi: 10.1152/japplphysiol.00538.2013. Epub 2013 Jun 20.
- Background: PubMed 20374963Ahmed K, Tunaru S, Tang C, Muller M, Gille A, Sassmann A, Hanson J, Offermanns S. An autocrine lactate loop mediates insulin-dependent inhibition of lipolysis through GPR81. Cell Metab. 2010 Apr 7;11(4):311-9. doi: 10.1016/j.cmet.2010.02.012.
- Background: PubMed 38324259Pedersen MGB, Rittig N, Bangshaab M, Berg-Hansen K, Gopalasingam N, Gormsen LC, Sondergaard E, Moller N. Effects of exogenous lactate on lipid, protein, and glucose metabolism-a randomized crossover trial in healthy males. Am J Physiol Endocrinol Metab. 2024 Apr 1;326(4):E443-E453. doi: 10.1152/ajpendo.00301.2023. Epub 2024 Feb 7.
- Background: PubMed 8214058Ferrannini E, Natali A, Brandi LS, Bonadonna R, De Kreutzemberg SV, DelPrato S, Santoro D. Metabolic and thermogenic effects of lactate infusion in humans. Am J Physiol. 1993 Sep;265(3 Pt 1):E504-12. doi: 10.1152/ajpendo.1993.265.3.E504.
- Background: PubMed 31253418Jones TE, Pories WJ, Houmard JA, Tanner CJ, Zheng D, Zou K, Coen PM, Goodpaster BH, Kraus WE, Dohm GL. Plasma lactate as a marker of metabolic health: Implications of elevated lactate for impairment of aerobic metabolism in the metabolic syndrome. Surgery. 2019 Nov;166(5):861-866. doi: 10.1016/j.surg.2019.04.017. Epub 2019 Jun 25.
- Individual participant dataSharing planned: Undecided. it will be shared upon request
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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.
Ricardo Mora Rodriguez, PhD principal investigator
University of Castilla-La Mancha
Jesus Garcia-Pallares, PhD principal investigator
Universidad de Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hyperlactacidemia and Saline (0.9%, sterile, for infusion) in people with Hyperlactatemia and Metabolic Syndrome (MetS), run by Ricardo Mora at 1 site in Spain.
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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ricardo MORA RODRIGUEZ, PhD (+34675424515, ricardo.mora@uclm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. 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 NCT07426172, which also lists 5 linked publications.
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 23 Feb 2026.