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Status unknownNCT03347305CALIMERO 2Updated Feb 4, 2019

Measurement of the Energy Metabolism of Peritoneal Dialysis Patients

An interventional study of automated DP and Calorimetric chamber in Renal Failure, sponsored by University Hospital, Clermont-Ferrand. Status unknown at 1 site in France. Open to male participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-04.

Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
Male
01

Study 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.

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.

02

Conditions studied

  • Renal Failure

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Keywords

  • Energy expenditure
  • Peritoneal dialysis
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Patients Group DPA

    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

    Behavioral: automated DP

  • Experimental
    Healthy Volunteers

    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

    Behavioral: Calorimetric chamber

Interventions

  • Behavioralautomated DP

    Energy expenditure measurement

  • BehavioralCalorimetric 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

05

What researchers measure

Primary outcomes

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

    Energy expenditure measured by indirect calorimetry in a calorimetric chamber

    Time frame: at day 1

Secondary outcomes

  1. respiratory quotient (RQ)

    Nature of the oxidized nutrients determined from the measurement of the respiratory quotient

    Time frame: at day1

  2. Actimetry

    Estimated ambulatory energy expenditure from heart rate

    Time frame: at day 1

  3. HGPO

    Charges of blood insulin concentration, and glucose in response to oral glucose load

    Time frame: at day 1

06

Study locations

1 of 1 sites recruiting
  • CHU Clermont-Ferrand
    Clermont-Ferrand, 63003, France
    • Patrick LACARIN · Contact · placarin@chu-clermontferrand.fr · 0473751195
    • Julien ANIORT · Principal investigator
    • Marc BOUILLER · Sub investigator
    • Myriam ISNARD · Sub investigator
    • Didier AGUILERA · Sub investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT03347305
Lead sponsor
University Hospital, Clermont-Ferrand
Collaborators
Pôle Santé République, Service de Néphrologie et Hémodialyse, Jacques Lacarin Hospital Center
Responsible party
Sponsor
First posted
Nov 20, 2017
Start date
Aug 1, 2016
Primary completion
Dec 31, 2019 (estimated)
Completion
Dec 31, 2019 (estimated)
Last update
Feb 4, 2019

Study contacts

Patrick LACARIN
Contact
placarin@chu-clermontferrand.fr
0473751195
Julien ANIORT
principal investigator · University Hospital, Clermont-Ferrand

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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