Clinical trial NCT01561404: Effect of the Inhibition of the Mammalian Target of Rapamycin on Metabolism and Exercise
Official title: Effect of the Inhibition of the Mammalian Target of Rapamycin on Metabolism and Exercise.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Disorder Related to Renal Transplantation
Exercise, Aerobic
Muscle Strength
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2012-03-23
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility criteria: 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 β 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.

Primary outcomes:
measure: Muscular strength
timeFrame: Change from baseline to 6-8 weeks after m-TOR conversion
measure: Oxygen consumption in the tissues
timeFrame: Change from baseline to 6-8 weeks after m-TOR conversion
Secondary outcomes:
measure: Anthropometric measures
timeFrame: Change from baseline to 6-8 weeks after m-TOR conversion
measure: Strength of the hand
timeFrame: Change from baseline to 6-8 weeks after m-TOR conversion
measure: Metabolic parameters- Cardioventilatory response
timeFrame: Change from baseline to 6-8 weeks after m-TOR conversion
measure: Metabolic parameters- Biochemical response
timeFrame: Change from baseline to 6-8 weeks after m-TOR conversion
measure: Glucose tolerance test
timeFrame: Change from baseline to 6-8 weeks after m-TOR conversion
measure: Blood pressure
timeFrame: Change from baseline to 6-8 weeks after m-TOR conversion
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Nephrology Department. Hospital Universitari de Bellvitge
state: Barcelone
Study officials:
affiliation: Nephrology Department Hospital Universitari de Bellvitge
name: Josep M. Cruzado, MD
role: PRINCIPAL_INVESTIGATOR
References: