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Measurement of the Energy Metabolism of Peritoneal Dialysis Patients (CALIMERO 2)

Primary Purpose

Renal Failure

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
automated DP
Calorimetric chamber
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Renal Failure focused on measuring Energy expenditure, Peritoneal dialysis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients Group DPA

    • Male patients
    • Aged 18 to 70 years
    • With end-stage renal disease
    • Treated by automatic peritoneal
    • Social security cover
    • 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

Exclusion Criteria:

  • • - 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

Sites / Locations

  • CHU Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patients Group DPA

Healthy Volunteers

Arm Description

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

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

Outcomes

Primary Outcome Measures

Energy expenditure measured by indirect calorimetry in a calorimetric chamber
Energy expenditure measured by indirect calorimetry in a calorimetric chamber

Secondary Outcome Measures

respiratory quotient (RQ)
Nature of the oxidized nutrients determined from the measurement of the respiratory quotient
Actimetry
Estimated ambulatory energy expenditure from heart rate
HGPO
Charges of blood insulin concentration, and glucose in response to oral glucose load

Full Information

First Posted
November 15, 2017
Last Updated
February 1, 2019
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Pôle Santé République, Service de Néphrologie et Hémodialyse, Jacques Lacarin Hospital Center
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1. Study Identification

Unique Protocol Identification Number
NCT03347305
Brief Title
Measurement of the Energy Metabolism of Peritoneal Dialysis Patients
Acronym
CALIMERO 2
Official Title
Study in Calorimetric Room of the Energy Metabolism of Renal Impairment Patients Treated With Automated Peritoneal Dialysis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Pôle Santé République, Service de Néphrologie et Hémodialyse, Jacques Lacarin Hospital Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure
Keywords
Energy expenditure, Peritoneal dialysis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
No masking
Allocation
Non-Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients Group DPA
Arm Type
Experimental
Arm Description
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
Arm Title
Healthy Volunteers
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
automated DP
Intervention Description
Energy expenditure measurement
Intervention Type
Behavioral
Intervention Name(s)
Calorimetric chamber
Intervention Description
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
Primary Outcome Measure Information:
Title
Energy expenditure measured by indirect calorimetry in a calorimetric chamber
Description
Energy expenditure measured by indirect calorimetry in a calorimetric chamber
Time Frame
at day 1
Secondary Outcome Measure Information:
Title
respiratory quotient (RQ)
Description
Nature of the oxidized nutrients determined from the measurement of the respiratory quotient
Time Frame
at day1
Title
Actimetry
Description
Estimated ambulatory energy expenditure from heart rate
Time Frame
at day 1
Title
HGPO
Description
Charges of blood insulin concentration, and glucose in response to oral glucose load
Time Frame
at day 1

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients Group DPA Male patients Aged 18 to 70 years With end-stage renal disease Treated by automatic peritoneal Social security cover 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 Exclusion Criteria: • - 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
0473751195
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien ANIORT
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
0473751195
Email
placarin@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Julien ANIORT
First Name & Middle Initial & Last Name & Degree
Marc BOUILLER
First Name & Middle Initial & Last Name & Degree
Myriam ISNARD
First Name & Middle Initial & Last Name & Degree
Didier AGUILERA

12. IPD Sharing Statement

Learn more about this trial

Measurement of the Energy Metabolism of Peritoneal Dialysis Patients

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