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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01800851
Acronym
CALIMERO
Enrollment
30
Registered
2013-02-28
Start date
2008-01-31
Completion date
2012-12-31
Last updated
2014-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Kidney transplantation, Energy expenditure, Weight gain, Insulin resistance

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.

Interventions

OTHEREnergy expenditure evaluation in calorimetric chamber

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
35 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Energy expenditureat day 1

Secondary

MeasureTime frame
Body compositionat day 1
Food intakeat day 1
Estimation of physical activityat day 1
Insulin resistanceat day 1

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026