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

Diabetes Clinical Trial

— CALIMERO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01800851
• Other study ID #: CHU-0146
• Secondary ID: 2007-A00287-46
• Status: Completed
• Phase: N/A
• First received: February 15, 2013
• Last updated: July 4, 2014
• Start date: January 2008
• Est. completion date: December 2012

Study information

• Verified date: July 2014
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

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

Intervention

Other:
• Energy expenditure evaluation in calorimetric chamber

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Agrément pour la Recherche Biomédicale n°03047S, Hopital Gabriel Montpied, Laboratoire Régional de Nutrition Humaine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Energy expenditure		at day 1	No
Secondary	Body composition		at day 1	No
Secondary	Food intake		at day 1	No
Secondary	Estimation of physical activity		at day 1	No
Secondary	Insulin resistance		at day 1	No