Muscle Strength Clinical Trial
— EXETOROfficial title:
Effect of the Inhibition of the Mammalian Target of Rapamycin on Metabolism and Exercise.
Verified date | April 2015 |
Source | Hospital Universitari de Bellvitge |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Spanish Agency of Medicines |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 3 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: 1. Renal transplant patient's aged between 18 and 60 years old. 2. Heart rate in radial pulse and seated between 50 and 100 bpm. 3. Systolic blood pressure between 100 and 140 and diastolic between 50 to 90. 4. Absence of any clinical physical, psychological or psychiatric condition that would prevent from the protocol described follow-up. 5. Estimated glomerular filtration rate greater than 40 ml / min. 6. Proteinuria < 0.5 g / d. 7. Renal transplantation at least 6 months ago. 8. Immunosuppressant based on calcineurin inhibitors. 9. Hemoglobin > 11 g / dl. 10. Body mass index (BMI) < 35 kg/m2. 11. Indication for conversion to everolimus and granting of written informed consent. Exclusion Criteria: 1. Diabetes mellitus 2. Treatment with erythropoiesis stimulating drugs 3. Treatment with ß blockers drugs 4. Participation in any clinical trial in the last 30 days prior to the inclusion. 5. Any other physical illness, psychological or psychiatric condition that could difficult the follow-up of the patient. |
Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Spain | Nephrology Department. Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | Barcelone |
Lead Sponsor | Collaborator |
---|---|
Josep M Cruzado |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | Metabolic parameters- Biochemical response | Lactate and blood glucose levels after stress test | Change from baseline to 6-8 weeks after m-TOR conversion | No |
Secondary | Glucose tolerance test | Change from baseline to 6-8 weeks after m-TOR conversion | No | |
Secondary | Blood pressure | Continuos blood preassure measure (24 hours) with a holter monitor device. | Change from baseline to 6-8 weeks after m-TOR conversion | No |
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