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

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.

Study Overview

• Status: Unknown
• Conditions: Renal Failure
• Intervention / Treatment: Behavioral: automated DP; Behavioral: 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 Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Recruiting
    • CHU Clermont-Ferrand
    • Principal Investigator: Julien ANIORT
    • Sub-Investigator: Marc BOUILLER
    • Sub-Investigator: Myriam ISNARD
    • Sub-Investigator: Didier AGUILERA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Energy expenditure measurement
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Energy expenditure measured by indirect calorimetry in a calorimetric chamber	Energy expenditure measured by indirect calorimetry in a calorimetric chamber	at day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
respiratory quotient (RQ)	Nature of the oxidized nutrients determined from the measurement of the respiratory quotient	at day1
Actimetry	Estimated ambulatory energy expenditure from heart rate	at day 1
HGPO	Charges of blood insulin concentration, and glucose in response to oral glucose load	at day 1

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Pôle Santé République; Service de Néphrologie et Hémodialyse; Jacques Lacarin Hospital Center

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: November 15, 2017
• First Submitted That Met QC Criteria: November 17, 2017
• First Posted (Actual): November 20, 2017

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Energy expenditure; Peritoneal dialysis
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: CHU-364; 2015-A00035-44 (Other Identifier: 2015-A00035-44)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No