How higher blood lactate affects fat and carbohydrate metabolism
Role of Elevated Lactate Levels on Lipid and Carbohydrate Metabolism.
NA · University of Castilla-La Mancha · NCT07426172
This test raises blood lactate with an IV in adults with and without metabolic syndrome to see if higher lactate lowers fat breakdown and worsens glucose tolerance.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Castilla-La Mancha (other) |
| Locations | 1 site (San Javier, Murcia) |
| Trial ID | NCT07426172 on ClinicalTrials.gov |
What this trial studies
This interventional study will enroll 10 metabolically healthy and 10 metabolically impaired adults matched for sex and activity. Metabolically healthy participants will undergo two visits—one with intravenous sodium lactate to raise blood lactate to levels seen in metabolic syndrome and one with saline—while metabolically impaired participants will undergo the saline visit. Each visit includes a 150-minute basal period, an exercise bout, and a 2-hour oral glucose tolerance test, with measurements of insulin sensitivity, substrate oxidation by indirect calorimetry, and glycerol/glucose turnover using stable isotopes. The design compares acute effects of elevated lactate on lipolysis and carbohydrate metabolism at rest, during exercise, and after glucose intake.
Who should consider this trial
Good fit: Ideal candidates are adults (>18) who are physically active, able to exercise, willing to undergo IV infusions and OGTTs, and either meet IDF criteria for metabolic syndrome or are metabolically healthy for the comparison group.
Not a fit: Patients with chronic illnesses that prevent exercise, pregnant women, or those judged unsuitable by the investigator are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could show whether lowering lactate or blocking lactate signaling might improve fat breakdown and blood sugar control in people with metabolic syndrome.
How similar studies have performed: Prior mechanistic and animal studies suggest lactate can act as a metabolic signal, but directly raising blood lactate in humans to mimic metabolic syndrome and measure effects on lipolysis and glucose tolerance is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
San Javier, Murcia
- Facultad de Ciencias del Deporte — San Javier, Murcia, Spain (RECRUITING)
Study contacts
- Principal investigator: Ricardo Mora Rodriguez, PhD — University of Castilla-La Mancha
- Study coordinator: Ricardo MORA RODRIGUEZ, PhD
- Email: ricardo.mora@uclm.es
- Phone: +34675424515
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hyperlactatemia, Metabolic Syndrome, Lipolysis, Exercise, blood lactate, lipolysis, oral glucose tolerance test, stable isotopes