Clinical trial NCT01800851: Calorimetry, Insulin Resistance and Energy Metabolism Study to Understand the Risk of Obesity in Kidney Transplanted Patients
Official title: Calorimetry, Insulin Resistance and Energy Metabolism Study to Understand the Risk of Obesity in Kidney Transplanted Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Renal Failure
Kidney Transplantation
Weight Gain
Insulin Resistance
Diabetes
Keywords: Kidney transplantation
Energy expenditure
Weight gain
Insulin resistance
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Laboratoire Régional de Nutrition Humaine
name: Hopital Gabriel Montpied
name: Agrément pour la Recherche Biomédicale n°03047S
First posted: 2013-02-28
Enrollment: 30
Sex: MALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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 risk and the long-term loss of graft function. Weight loss achieved by a suitable dietary intervention in these patients transplanted kidney can correct lipid disorders and facilitate balance blood pressure. The identification of mechanisms responsible for weight gain would suggest prevention strategies and allow to align the caloric energy needs of renal transplant patients.

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 risk and the long-term loss of graft function. Weight loss achieved by a suitable dietary intervention in these patients transplanted kidney can correct lipid disorders and facilitate balance blood pressure. The identification of mechanisms responsible for weight gain would suggest prevention strategies and allow to align the caloric energy needs of renal transplant patients.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Energy expenditure
timeFrame: at day 1
Secondary outcomes:
measure: Body composition
timeFrame: at day 1
measure: Food intake
timeFrame: at day 1
measure: Estimation of physical activity
timeFrame: at day 1
measure: Insulin resistance
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Anne-Elisabeth HENG
role: PRINCIPAL_INVESTIGATOR
References: