Chronic Renal FailureCALIMERONCT01800851
Calorimetry, Insulin Resistance and Energy Metabolism Study to Understand the Risk of Obesity in Kidney Transplanted Patients
A study testing Energy expenditure evaluation in calorimetric chamber in people with Chronic Renal Failure and Kidney Transplantation, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 35 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Renal Failure, Kidney Transplantation, Weight Gain
- What is being tested?
- Energy expenditure evaluation in calorimetric chamber
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2008to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Energy expenditure evaluation in calorimetric chamber
- Keywords
- Kidney transplantation, Energy expenditure, Weight gain, Insulin resistance
- Medical subject headings
- Kidney Failure, Chronic, Weight Gain, Insulin Resistance, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy expenditure evaluation in calorimetric chamberOther
| Study group | Role | What they receive |
|---|---|---|
| no weight gain | Experimental | The characteristics of the renal transplant patients are compared with those of 10 healthy volunteers matched for age and lean body mass Receives: Other: Energy expenditure evaluation in calorimetric chamber |
| weight gain | Experimental | The characteristics of the renal transplant patients are compared with those of 10 healthy volunteers matched for age and lean body mass Receives: Other: Energy expenditure evaluation in calorimetric chamber |
| lean body mass | Other | The characteristics of the renal transplant patients are compared with those of 10 healthy volunteers matched for age and lean body mass Receives: Other: Energy expenditure evaluation in calorimetric chamber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy expenditure
Measured: at day 1
Secondary outcomes (4)
Body composition
Measured: at day 1
Food intake
Measured: at day 1
Estimation of physical activity
Measured: at day 1
Insulin resistance
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2013 (estimated)
- Study startJan 2008
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire Régional de Nutrition Humaine, Hopital Gabriel Montpied, Agrément pour la Recherche Biomédicale n°03047S
- Responsible party
- Sponsor
- Investigators
- Anne-Elisabeth HENG, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01800851
- Sponsor's protocol ID
- CHU-0146
- Other IDs
- 2007-A00287-46
- Acronym
- CALIMERO
- Status last verified
- Jul 2014
- First submitted
- 15 Feb 2013
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calorimetry, Insulin Resistance and Energy Metabolism Study to Understand the Risk of Obesity in Kidney Transplanted Patients
- ClinicalTrials.gov ID
- NCT01800851
- Acronym / sponsor ID
- CALIMERO / CHU-0146
- Keywords
- Kidney transplantation, Energy expenditure, Weight gain, Insulin resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Laboratoire Régional de Nutrition Humaine, Hopital Gabriel Montpied, Agrément pour la Recherche Biomédicale n°03047S
- Study start
- Jan 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| no weight gain | Experimental | Other: Energy expenditure evaluation in calorimetric chamberThe characteristics of the renal transplant patients are compared with those of 10 healthy volunteers matched for age and lean body mass |
| weight gain | Experimental | Other: Energy expenditure evaluation in calorimetric chamberThe characteristics of the renal transplant patients are compared with those of 10 healthy volunteers matched for age and lean body mass |
| lean body mass | Other | Other: Energy expenditure evaluation in calorimetric chamberThe characteristics of the renal transplant patients are compared with those of 10 healthy volunteers matched for age and lean body mass |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Energy expenditure evaluation in calorimetric chamber | Other | lean body mass, no weight gain, weight gain |
Primary outcome
Energy expenditure
Time frame: at day 1
4 secondary outcomes
Body composition
Time frame: at day 1
Food intake
Time frame: at day 1
Estimation of physical activity
Time frame: at day 1
Insulin resistance
Time frame: at day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Elisabeth HENG principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Energy expenditure evaluation in calorimetric chamber in people with Chronic Renal Failure and Kidney Transplantation, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy expenditure (time frame: at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2014.