Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-010541-31 | EudraCT Number |
Not provided
Not provided
lack of potential patients
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Everolimus | Experimental | Conversion from calcineurin inhibitor (CNI) to MTOR inhibitor (everolimus) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Muscular strength | The principal variable is the increase of the exercise capacity measured by 2 sub-varibles: muscular strenght and decrease of oxygen consumption in the tissues. | Change from baseline to 6-8 weeks after m-TOR conversion |
| Oxygen consumption in the tissues | The principal variable is the increase of the exercise capacity measured by 2 sub-varibles: muscular strenght and decrease of oxygen consumption in the tissues. | Change from baseline to 6-8 weeks after m-TOR conversion |
| Measure | Description | Time Frame |
|---|---|---|
| Anthropometric measures | Measure of anthropometric measures including height,weight, muscular folds( biceps, triceps, subscapular, pectoral, axillary, abdominal, suprailiac, thigh and leg) and perimeters (arm, forearm, wrist, abdominal, waist, hip, thigh, groin, thigh and leg). | Change from baseline to 6-8 weeks after m-TOR conversion |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Josep M. Cruzado, MD | Nephrology Department Hospital Universitari de Bellvitge | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nephrology Department. Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | Barcelone | 08907 | Spain |
Not provided
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Strength of the hand |
Measure of the strenght of the hand will include:test of maximum strength of contraction of the palm, maximum resistance force of the palm and maximum power on a cycle ergometer for 5 seconds with a constant resistance of 50 N. |
| Change from baseline to 6-8 weeks after m-TOR conversion |
| Metabolic parameters- Cardioventilatory response | Cardioventilatory response measured with respiratory rate, ventilation, oxygen consumption, carbon dioxide production, respiratory quotient and tidal volume during stress test. | Change from baseline to 6-8 weeks after m-TOR conversion |
| Metabolic parameters- Biochemical response | Lactate and blood glucose levels after stress test | Change from baseline to 6-8 weeks after m-TOR conversion |
| Glucose tolerance test | Change from baseline to 6-8 weeks after m-TOR conversion |
| Blood pressure | Continuos blood preassure measure (24 hours) with a holter monitor device. | Change from baseline to 6-8 weeks after m-TOR conversion |