Measurement of the Energy Metabolism of Peritoneal Dialysis Patients

Not Applicable

• Conditions: Renal Failure

• Registration Number: NCT03347305
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study Start: 2016-08-01
• Study First Submitted: 2017-11-15
• Study First Submitted QC: 2017-11-17
• Study First Posted: 2017-11-20
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Energy expenditure measured by indirect calorimetry in a calorimetric chamber	at day 1	Energy expenditure measured by indirect calorimetry in a calorimetric chamber

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France