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

NCT ID: NCT01800851

Last Updated: 2014-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2012-12-31

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.

Conditions

Chronic Renal Failure; Kidney Transplantation; Weight Gain; Insulin Resistance; Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Energy expenditure evaluation in calorimetric chamber

Intervention Type: OTHER

weight gain

The characteristics of the renal transplant patients are compared with those of 10 healthy volunteers matched for age and lean body mass

Group Type: EXPERIMENTAL

Energy expenditure evaluation in calorimetric chamber

Intervention Type: 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

Group Type: OTHER

Energy expenditure evaluation in calorimetric chamber

Intervention Type: OTHER

Interventions

Energy expenditure evaluation in calorimetric chamber

Intervention Type: OTHER

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Laboratoire Régional de Nutrition Humaine

OTHER

Sponsor Role: collaborator

Hopital Gabriel Montpied

OTHER

Sponsor Role: collaborator

Agrément pour la Recherche Biomédicale n°03047S

UNKNOWN

Sponsor Role: collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne-Elisabeth HENG

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU Clermont-Ferrand

Clermont-Ferrand, , France

Countries

France

Other Identifiers

2007-A00287-46

Identifier Type: -

Identifier Source: secondary_id

CHU-0146

Identifier Type: -

Identifier Source: org_study_id