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

Not Applicable

Completed

• Conditions: Kidney Transplantation; Weight Gain; Insulin Resistance; Chronic Renal Failure; Diabetes
• Interventions: Other: Energy expenditure evaluation in calorimetric chamber

• Registration Number: NCT01800851
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2013-02-15
• Study First Submitted QC: 2013-02-26
• Study First Posted: 2013-02-28
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-04
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
no weight gain	Energy expenditure evaluation in calorimetric chamber	The characteristics of the renal transplant patients are compared with those of 10 healthy volunteers matched for age and lean body mass
weight gain	Energy expenditure evaluation in calorimetric chamber	The characteristics of the renal transplant patients are compared with those of 10 healthy volunteers matched for age and lean body mass
lean body mass	Energy expenditure evaluation in calorimetric chamber	The characteristics of the renal transplant patients are compared with those of 10 healthy volunteers matched for age and lean body mass

Primary Outcome Measures

Name	Time	Method
Energy expenditure	at day 1

Secondary Outcome Measures

Name	Time	Method
Food intake	at day 1
Insulin resistance	at day 1
Body composition	at day 1
Estimation of physical activity	at day 1

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France