Calorimetry, Insulin Resistance and Energy Metabolism Study to Understand the Risk of Obesity in Kidney Transplanted Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Calorimetry, Insulin Resistance and Energy Metabolism Study to Understand the Risk of Obesity in Kidney Transplanted Patients

Conditions
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Chronic Renal Failure, Kidney Transplantation, Weight Gain, Insulin Resistance, Diabetes

Intervention / Treatment
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* Other: Energy expenditure evaluation in calorimetric chamber


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: no weight gain<br>The characteristics of the renal transplant patients are compared with those of 10 healthy volunteers matched for age and lean body mass | Other: Energy expenditure evaluation in calorimetric chamber<br> <br> |
| Experimental: weight gain<br>The characteristics of the renal transplant patients are compared with those of 10 healthy volunteers matched for age and lean body mass | Other: Energy expenditure evaluation in calorimetric chamber<br> <br> |
| Other: lean body mass<br>The characteristics of the renal transplant patients are compared with those of 10 healthy volunteers matched for age and lean body mass | Other: Energy expenditure evaluation in calorimetric chamber<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy expenditure |  | at day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition |  | at day 1 | 
| Food intake |  | at day 1 | 
| Estimation of physical activity |  | at day 1 | 
| Insulin resistance |  | at day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney transplantation, Energy expenditure, Weight gain, Insulin resistance