Effects of medication and meal timing on exercise for metabolic syndrome
Optimizing Exercise Training Effects on Metabolic Syndrome Factors by Altering the Timing of Medication and Meal Ingestion
This study is testing how the timing of meals and medication around exercise can help adults with metabolic syndrome improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Castilla-La Mancha Academic / other |
| Locations | 1 site (Toledo) |
| Trial ID | NCT04477590 on ClinicalTrials.gov |
What this trial studies
This study aims to analyze how the timing of medication intake and meals around exercise training affects individuals with metabolic syndrome. It will involve a cross-over randomized double-blinded design, where participants will engage in exercise training either in a fasted or fed state while taking their usual medications. The goal is to determine the optimal combination of exercise, meal timing, and medication to improve factors associated with metabolic syndrome, such as hypertension and insulin sensitivity. Up to 180 adults diagnosed with metabolic syndrome will be recruited for this study.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with metabolic syndrome who are not hindered by cardiovascular or musculoskeletal conditions.
Not a fit: Patients with existing cardiovascular disease, respiratory failure, liver or renal disease, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with metabolic syndrome, enhancing their health outcomes.
How similar studies have performed: While the specific combination of medication and meal timing with exercise is novel, similar studies have shown promising results in improving metabolic health through lifestyle interventions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Metabolic syndrome patients diagnosed according to The International diabetes federation consensus of 2009 (Alberti, et al., Circulation). Exclusion Criteria: * Cardiovascular disease or musculo-skeletal that prevents them from being able to perform intense exercise. * Respiratory failure * Liver o renal disease * Pregnancy
Where this trial is running
Toledo
- University of Castilla-La Mancha (Exercise Physiology Lab) — Toledo, Spain (Recruiting)
Study contacts
- Principal investigator: RICARDO M Mora-Rodriguez, PhD — University of Castilla-La Mancha
- Study coordinator: Ricardo Mora-Rodriguez, PhD
- Email: ricardo.mora@uclm.es
- Phone: 925268800
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.