An interventional study of hyperlactacidemia and Saline (0.9%, sterile, for infusion) in Hyperlactatemia, Metabolic Syndrome (MetS) and Lipolysis, sponsored by Ricardo Mora. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-23.
Sponsored by Ricardo Mora · Not applicable, Interventional, and Basic science
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.
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.
50 studies on the registry are indexed under Hyperlactatemia; 7 are open to participants now.
This study's planned enrollment of 24 is below the median of 38 across 32 interventional studies indexed under Hyperlactatemia.
Browse Hyperlactatemia studies →This is the only study on the registry with Ricardo Mora as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metabolically Healthy Individuals
Other: hyperlactacidemia · Other: Saline (0.9%, sterile, for infusion)
Metabolic Syndrome Individuals
Other: Saline (0.9%, sterile, for infusion)
Raise blood lactate in metabolically healthy individuals to the levels of individuals with metabolic syndrome
Saline infusion as a control treatment
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
Time frame: 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
Time frame: through study completion, an average of 2 years
Insulin sensitivity
The difference between groups and interventions in Matsuda ISI during the glucose tolerance test
Time frame: through study completion, an average of 2 years
Indirect calorimetry
Changes in fat and carbohydrate oxidation during treatments in both groups.
Time frame: through study completion, an average of 2 years
Blood sample-insulin
Insulin concentrations. Difference between interventions and groups
Time frame: through study completion, an average of 2 years
Blood samples - glucose
Glucose concentrations. Difference between interventions and groups
Time frame: through study completion, an average of 2 years
Blood samples - Free fatty acids
Free fatty acids concentration. Difference between interventions and groups
Time frame: through study completion, an average of 2 years
Blood samples - Glycerol
Glycerol concentrations. Difference between interventions and groups
Time frame: through study completion, an average of 2 years
Blood samples - Lactate
lactate concentrations. Difference between interventions and groups
Time frame: 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
Time frame: through study completion, an average of 2 years
13CO2 / 12CO2 in expired air
Analisys of 13CO2 / 12CO2 by IRMS
Time frame: 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
Time frame: 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
Time frame: through study completion, an average of 2 years
Plan to share: Undecided — it will be shared upon request
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