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

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 Overview

• Status: Completed
• Conditions: Diabetes; Insulin Resistance; Kidney Transplantation; Weight Gain; Chronic Renal Failure
• Intervention / Treatment: Other: Energy expenditure evaluation in calorimetric chamber

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Chu Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: no weight gain; 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
Experimental: weight gain; 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
Other: lean body mass; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Energy expenditure	at day 1

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Hopital Gabriel Montpied; Laboratoire Régional de Nutrition Humaine; Agrément pour la Recherche Biomédicale n°03047S
• Investigators: Principal Investigator: Anne-Elisabeth HENG, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: February 15, 2013
• First Submitted That Met QC Criteria: February 26, 2013
• First Posted (Estimate): February 28, 2013

Study Record Updates

• Last Update Posted (Estimate): July 8, 2014
• Last Update Submitted That Met QC Criteria: July 4, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Energy expenditure; Insulin resistance; Kidney transplantation; Weight gain
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Body Weight; Hyperinsulinism; Body Weight Changes; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Insulin Resistance; Weight Gain
• Other Study ID Numbers: CHU-0146; 2007-A00287-46