Effect of the Inhibition of the Mammalian Target of Rapamycin on Metabolism and Exercise (EXETOR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Hospital Universitari de Bellvitge.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Josep M Cruzado, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier:
NCT01561404
First received: March 20, 2012
Last updated: March 21, 2012
Last verified: March 2012

March 20, 2012
March 21, 2012
September 2011
December 2013   (final data collection date for primary outcome measure)
  • Muscular strength [ Time Frame: Change from baseline to 6-8 weeks after m-TOR conversion ] [ Designated as safety issue: No ]
    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.
  • Oxygen consumption in the tissues [ Time Frame: Change from baseline to 6-8 weeks after m-TOR conversion ] [ Designated as safety issue: No ]
    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.
Same as current
Complete list of historical versions of study NCT01561404 on ClinicalTrials.gov Archive Site
  • Anthropometric measures [ Time Frame: Change from baseline to 6-8 weeks after m-TOR conversion ] [ Designated as safety issue: No ]
    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).
  • Strength of the hand [ Time Frame: Change from baseline to 6-8 weeks after m-TOR conversion ] [ Designated as safety issue: No ]
    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.
  • Metabolic parameters- Cardioventilatory response [ Time Frame: Change from baseline to 6-8 weeks after m-TOR conversion ] [ Designated as safety issue: No ]
    Cardioventilatory response measured with respiratory rate, ventilation, oxygen consumption, carbon dioxide production, respiratory quotient and tidal volume during stress test.
  • Metabolic parameters- Biochemical response [ Time Frame: Change from baseline to 6-8 weeks after m-TOR conversion ] [ Designated as safety issue: No ]
    Lactate and blood glucose levels after stress test
  • Glucose tolerance test [ Time Frame: Change from baseline to 6-8 weeks after m-TOR conversion ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: Change from baseline to 6-8 weeks after m-TOR conversion ] [ Designated as safety issue: No ]
    Continuos blood preassure measure (24 hours) with a holter monitor device.
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 4
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Disorder Related to Renal Transplantation
  • Exercise, Aerobic
  • Muscle Strength
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.
Other Name: m-TOR inhibitor(Everolimus)in kidney transplant recipients
Experimental: Everolimus
Conversion from calcineurin inhibitor (CNI) to MTOR inhibitor (everolimus)
Intervention: Drug: Everolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
April 2014
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
No
Contact: Josep M. Cruzado, MD +34932607385 jcruzado@bellvitgehospital.cat
Contact: Carol Polo, PhD +932607385 cpolo@idibell.cat
Spain
 
NCT01561404
MTOR-METAB, 2009-010541-31
No
Josep M Cruzado, Hospital Universitari de Bellvitge
Josep M Cruzado
Not Provided
Principal Investigator: Josep M. Cruzado, MD Nephrology Department Hospital Universitari de Bellvitge
Hospital Universitari de Bellvitge
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP