Renal FailureCALIMERO 2NCT03347305
Measurement of the Energy Metabolism of Peritoneal Dialysis Patients
A study testing automated DP and Calorimetric chamber in people with Renal Failure, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The daily energy expenditure of patients treated with peritoneal dialysis could be increased compared to the general population and promote the development of a state of undernutrition. Conversely, the absorption of glucose by transperitoneal route could contribute to the occurrence of a metabolic syndrome. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Renal Failure
- What is being tested?
- automated DP and Calorimetric chamber
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2016to 31 Dec 2019
- 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 18 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients Group DPA
- Male patients
- Aged 18 to 70 years
- With end-stage renal disease
- Treated by automatic peritoneal
- Social security cover
Show all 19Show fewer
- Without acute events in the 3 months prior to inclusion
- PCR < 30 mg/L
- Written informed consent
- Baecke activity score from 5 to 10
- Healthy Volunteers
- Male patients
- Aged 18 to 70 years
- Patients matched by lean body mass (± 2 kgs) and age (± 5 years)
- Having a glomerular filtration rate estimated with the formula CKD-EPI creatinine > 60 mL / min / 1.73 m 2
- PCR < 3 mg/L
- Social security cover
- Written informed consent
- Baecke activity score from 5 to 10
Who cannot join
- • - Female
- Type 1 or 2 diabetes requiring a antidiabetic treatment
- Decompensated heart failure
- Smoking more than 5 cigarettes a day
- Alcoholic patients, drinking more than 3 glass of alcohol a day
- Patient Corticotherapy in progress
- Patient with evolutive acute pathology
- Person who has participated in another study within the last 30 days or is in period of exclusion on the National File of Healthy Volunteers
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 0473751195, placarin@chu-clermontferrand.fr
Julien ANIORT
About this study
Official title: Study in Calorimetric Room of the Energy Metabolism of Renal Impairment Patients Treated With Automated Peritoneal Dialysis
The daily energy expenditure of patients treated with peritoneal dialysis could be increased compared to the general population and promote the development of a state of undernutrition. Conversely, the absorption of glucose by transperitoneal route could contribute to the occurrence of a metabolic syndrome.
The main objective is to compare DE and its variations according to the conditions (rest, sleep, meals, physical activity) in patients treated with automated DP compared to controls, in a calorimetric chamber.
Read the detailed description
The daily energy expenditure of patients treated with peritoneal dialysis could be increased compared to the general population and promote the development of a state of undernutrition. Conversely, the absorption of glucose by transperitoneal route could contribute to the occurrence of a metabolic syndrome.
The main objective is to compare DE and its variations according to the conditions (rest, sleep, meals, physical activity) in patients treated with automated DP compared to controls, in a calorimetric chamber.
- Conditions
- Renal Failure
- Being tested
- automated DP, Calorimetric chamber
- Keywords
- Energy expenditure, Peritoneal dialysis
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
automated DPBehavioural
Energy expenditure measurement
Calorimetric chamberBehavioural
The main objective is to compare DE and its variations according to the conditions (rest, sleep, meals, physical activity) in patients treated with automated DP compared to controls, in a calorimetric chamber
| Study group | Role | What they receive |
|---|---|---|
| Patients Group DPA | Experimental | The main objective is to compare DE and its variations according to the conditions (rest, sleep, meals, physical activity) in patients treated with automated DP compared to controls, in a calorimetric chamber Receives: Behavioral: automated DP |
| Healthy Volunteers | Experimental | The main objective is to compare DE and its variations according to the conditions (rest, sleep, meals, physical activity) in patients treated with automated DP compared to controls, in a calorimetric chamber Receives: Behavioral: Calorimetric chamber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy expenditure measured by indirect calorimetry in a calorimetric chamber
Energy expenditure measured by indirect calorimetry in a calorimetric chamber
Measured: at day 1
Secondary outcomes (3)
respiratory quotient (RQ)
Nature of the oxidized nutrients determined from the measurement of the respiratory quotient
Measured: at day1
Actimetry
Estimated ambulatory energy expenditure from heart rate
Measured: at day 1
HGPO
Charges of blood insulin concentration, and glucose in response to oral glucose load
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 posted20 Nov 2017
- Study start1 Aug 2016
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Pôle Santé République, Service de Néphrologie et Hémodialyse, Jacques Lacarin Hospital Center
- Responsible party
- Sponsor
- Investigators
- Julien ANIORT, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347305
- Sponsor's protocol ID
- CHU-364
- Other IDs
- 2015-A00035-44
- Acronym
- CALIMERO 2
- Status last verified
- Feb 2019
- First submitted
- 15 Nov 2017
- Last updated
- 4 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study in Calorimetric Room of the Energy Metabolism of Renal Impairment Patients Treated With Automated Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT03347305
- Acronym / sponsor ID
- CALIMERO 2 / CHU-364
- Conditions
- Renal Failure
- Keywords
- Energy expenditure, Peritoneal dialysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Pôle Santé République, Service de Néphrologie et Hémodialyse, Jacques Lacarin Hospital Center
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 20 Nov 2017 (actual)
- 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.
The daily energy expenditure of patients treated with peritoneal dialysis could be increased compared to the general population and promote the development of a state of undernutrition. Conversely, the absorption of glucose by transperitoneal route could contribute to the occurrence of a metabolic syndrome.
The main objective is to compare DE and its variations according to the conditions (rest, sleep, meals, physical activity) in patients treated with automated DP compared to controls, in a calorimetric chamber.
Detailed description
The daily energy expenditure of patients treated with peritoneal dialysis could be increased compared to the general population and promote the development of a state of undernutrition. Conversely, the absorption of glucose by transperitoneal route could contribute to the occurrence of a metabolic syndrome.
The main objective is to compare DE and its variations according to the conditions (rest, sleep, meals, physical activity) in patients treated with automated DP compared to controls, in a calorimetric chamber.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients Group DPA | Experimental | Behavioral: automated DPThe main objective is to compare DE and its variations according to the conditions (rest, sleep, meals, physical activity) in patients treated with automated DP compared to controls, in a calorimetric chamber |
| Healthy Volunteers | Experimental | Behavioral: Calorimetric chamberThe main objective is to compare DE and its variations according to the conditions (rest, sleep, meals, physical activity) in patients treated with automated DP compared to controls, in a calorimetric chamber |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients Group DPA
- Healthy Volunteers
- Male patients
- Aged 18 to 70 years
- Patients matched by lean body mass (± 2 kgs) and age (± 5 years)
Key exclusion criteria (8 listed)
- • - Female
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 |
|---|---|---|
| automated DPEnergy expenditure measurement | Behavioural | Patients Group DPA |
| Calorimetric chamberThe main objective is to compare DE and its variations according to the conditions (rest, sleep, meals, physical activity) in patients treated with automated DP compared to controls, in a calorimetric chamber | Behavioural | Healthy Volunteers |
Primary outcome
Energy expenditure measured by indirect calorimetry in a calorimetric chamber
Time frame: at day 1
Energy expenditure measured by indirect calorimetry in a calorimetric chamber
3 secondary outcomes
respiratory quotient (RQ)
Time frame: at day1
Actimetry
Time frame: at day 1
HGPO
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
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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.
Julien ANIORT 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 automated DP and Calorimetric chamber in people with Renal Failure, 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 19 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 4 Feb 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (0473751195, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy expenditure measured by indirect calorimetry in a calorimetric chamber (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 4 Feb 2019.