Role of Elevated Lactate Levels on Lipid and Carbohydrate Metabolism.
LACTMET
1 other identifier
interventional
24
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 20, 2026
CompletedFirst Submitted
Initial submission to the registry
February 8, 2026
CompletedFirst Posted
Study publicly available on registry
February 23, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2028
February 23, 2026
February 1, 2026
2 years
February 8, 2026
February 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
through study completion, an average of 2 years
Secondary Outcomes (11)
Insulin sensitivity
through study completion, an average of 2 years
Indirect calorimetry
through study completion, an average of 2 years
Blood sample-insulin
through study completion, an average of 2 years
Blood samples - glucose
through study completion, an average of 2 years
Blood samples - Free fatty acids
through study completion, an average of 2 years
- +6 more secondary outcomes
Study Arms (2)
Metabolically Healthy Individuals
PLACEBO COMPARATORMetabolically Healthy Individuals
Metabolic Syndrome Individuals
ACTIVE COMPARATORMetabolic Syndrome Individuals
Interventions
Raise blood lactate in metabolically healthy individuals to the levels of individuals with metabolic syndrome
Saline infusion as a control treatment
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Chronic illness that prevents them from exercising
- Affected blood samples at screening, as assessed by the PI
- Assessed as unsuitable by PI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ricardo Moralead
- University of Castilla-La Manchacollaborator
Study Sites (1)
Facultad de Ciencias del Deporte
San Javier, Murcia, 30720, Spain
Related Publications (5)
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.
PMID: 23788576BACKGROUNDAhmed 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.
PMID: 20374963BACKGROUNDPedersen 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.
PMID: 38324259BACKGROUNDFerrannini 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.
PMID: 8214058BACKGROUNDJones 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.
PMID: 31253418BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ricardo Mora Rodriguez, PhD
University of Castilla-La Mancha
- PRINCIPAL INVESTIGATOR
Jesus Garcia-Pallares, PhD
Universidad de Murcia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Head of the Exercise Physiology Laboratory at the University of Castilla-La Mancha
Study Record Dates
First Submitted
February 8, 2026
First Posted
February 23, 2026
Study Start
January 20, 2026
Primary Completion (Estimated)
January 30, 2028
Study Completion (Estimated)
September 30, 2028
Last Updated
February 23, 2026
Record last verified: 2026-02