Status:
COMPLETED
Calorimetry, Insulin Resistance and Energy Metabolism Study to Understand the Risk of Obesity in Kidney Transplanted Patients
Lead Sponsor:
University Hospital, Clermont-Ferrand
Collaborating Sponsors:
Laboratoire Régional de Nutrition Humaine
Hopital Gabriel Montpied
Conditions:
Chronic Renal Failure
Kidney Transplantation
Eligibility:
MALE
35-65 years
Phase:
NA
Brief Summary
Weight gain is a common complication after transplantation. It has adverse effects such as hypertension, dyslipidemia, and insulin resistance. Weight gain is implicated in the increased cardiovascular...
Detailed Description
Weight gain is a common complication after transplantation. It has adverse effects such as hypertension, dyslipidemia, and insulin resistance. Weight gain is implicated in the increased cardiovascular...
Eligibility Criteria
Inclusion
- Male patient, affiliated to a social security system
- Aged 35 to 65 years
- Renal transplant for more than a year and less than 6 years
- Treated by anticalcineurin
- Patient stopped all treatment with corticosteroids for more than 3 months
- Patient with stable renal function defined by a calculated creatinine clearance between 30 and 90 mL/min/1, 73m according to the Cockcroft and Gault
- Written informed consent after detailed explanation of the protocol.
- Increase in body weight of at least 3kg during the two years prior to the inclusion of 10 patients. Stable or increasing weight less than 1kg for 10 other patients.
- HIV and HCV serology negative
Exclusion
- Female patients
- Diabetic (type 1 or type 2) before transplantation or patients who developed diabetes after transplantation and requiring anti-diabetic treatment at the time of inclusion
- Obese patient at the time of transplantation, as defined by a body mass index\> 30%
- Multiple kidney transplant or other organ transplant the kidney
- Patient with lower limb edema, congestive heart failure, and/or uncontrolled hypertension.
- Patient with a change in body weight\> 3 kg in the last 3 months
- Patient with an infection 3 months before inclusion
- Subjects infected with hepatitis B, hepatitis C virus or human immunodeficiency
- Patient with acute rejection within 3 months prior to inclusion
- Patient not treated by anticalcineurin
- Patient with a modification of immunosuppressive therapy within 3 months prior to inclusion
- Patient with unstable psychiatric condition
- Patient smoking\> 5 cigarettes / day
- Alcoholic patient (unweaned)
- Patient with stage 4 renal failure (\<30 mL/min/1, 73m ²) and stage 5 (\<15 mL/min/1, 73m ²)
- hemodialysis patient
- Patient with acute renal failure defined by a 25% increase in creatinine within 3 months prior to inclusion
- Person under guardianship or not subject to social security
- Person in period Exclusion File National Healthy Volunteers
- Person who refuses to give his written consent to participation
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01800851
Start Date
January 1 2008
End Date
December 1 2012
Last Update
July 8 2014
Active Locations (1)
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1
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003