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

NCT ID: NCT01561404

Last Updated: 2015-04-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-12-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Everolimus

Conversion from calcineurin inhibitor (CNI) to MTOR inhibitor (everolimus)

Group Type: EXPERIMENTAL

Everolimus

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

m-TOR inhibitor(Everolimus)in kidney transplant recipients

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Josep M Cruzado

OTHER

Sponsor Role: lead

Responsible Party

Josep M Cruzado

NEPHROLOGIST

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Josep M. Cruzado, MD

Role: PRINCIPAL_INVESTIGATOR

Nephrology Department Hospital Universitari de Bellvitge

Locations

Nephrology Department. Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelone, Spain

Countries

Spain

Other Identifiers

2009-010541-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MTOR-METAB

Identifier Type: -

Identifier Source: org_study_id