NCT01561404

Effect of the Inhibition of the Mammalian Target of Rapamycin on Metabolism and Exercise

Effect of the Inhibition of the Mammalian Target of Rapamycin on Metabolism and Exercise.

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Josep M Cruzado · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This is an exploratory study based on the hypothesis that kidney transplant patients treated with an immunosuppressive therapy based on an inhibitor of the mammalian target of rapamycin (m-TOR) may increase resistance to physical exercise, which would result in an improvement in the quality of life of these patients.

Detailed description

The hypothesis of the present study is that, with respect to calcineurin inhibitors, the mTOR inhibitor-based immunosuppression may alter the physical exercise capacity in renal transplant patients. This is based on recent data obtained. Regarding metabolism there is evidence that inhibition of mTOR, reduces muscle glucose utilization, as well as, increase fatty acid oxidation. On the other hand, has shown that drugs based on mTOR inhibitors in the context of excess of nutrients improves intracellular glucose uptake in skeletal muscle cells. Through these mechanisms could increase resistance to physical exercise, which would result in an improvement in the quality of life of patients. Nevertheless, there isn't any paper that has explored this hypothesis accurately.

Conditions

• Disorder Related to Renal Transplantation
• Exercise, Aerobic
• Muscle Strength

Interventions

Type	Name	Description
DRUG	Everolimus	In patients that change of immunosuppressive therapy from calcineurin inhibitor (CNI)(tacrolimus or cyclosporine) to m-TOR (everolimus)has been clinically indicated, check if there is an increase in physical exercise capacity.

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2012-03-23
• Last updated: 2015-04-28

Locations

1 site across 1 country: Spain