Role of Elevated Lactate Levels on Lipid and Carbohydrate Metabolism.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorRicardo Mora
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Men and women
>18 years of age
Women non-pregnant or taking contraceptive medication
Physically active according to WHO's guidelines
Disqualifiers
Chronic illness that prevents them from exercising
Affected blood samples at screening, as assessed by the PI
Assessed as unsuitable by PI
Trial design
Design model
Crossover
Treatments tested in this trial
hyperlactacidemia
Other interventionRaise blood lactate in metabolically healthy individuals to the levels of individuals with metabolic syndrome
Saline (0.9%, sterile, for infusion)
Other interventionSaline infusion as a control treatment
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Metabolically Healthy IndividualsPlacebo comparator 2 interventions
Group B: Metabolic Syndrome IndividualsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 years2
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 yearsSecondary outcomes
1
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 years2
Indirect calorimetry
Changes in fat and carbohydrate oxidation during treatments in both groups.
Time frame
through study completion, an average of 2 years3
Blood sample-insulin
Insulin concentrations. Difference between interventions and groups
Time frame
through study completion, an average of 2 years4
Blood samples - glucose
Glucose concentrations. Difference between interventions and groups
Time frame
through study completion, an average of 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ricardo Mora
Lead sponsor
University of Castilla-La Mancha
Sponsor institution
University of Castilla-La Mancha
Collaborator
Source ClinicalTrials.gov