Measurement of the Energy Metabolism of Peritoneal Dialysis Patients

Renal Failure Clinical Trial

— CALIMERO 2  

Official title:

Study in Calorimetric Room of the Energy Metabolism of Renal Impairment Patients Treated With Automated Peritoneal Dialysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03347305
• Other study ID #: CHU-364
• Secondary ID: 2015-A00035-44
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2019
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 0473751195
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Renal Failure
• Renal Insufficiency

Intervention

Behavioral:
• automated DP
Energy expenditure measurement
• 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

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Jacques Lacarin Hospital Center, Pôle Santé République, Service de Néphrologie et Hémodialyse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Energy expenditure measured by indirect calorimetry in a calorimetric chamber	Energy expenditure measured by indirect calorimetry in a calorimetric chamber	at day 1
Secondary	respiratory quotient (RQ)	Nature of the oxidized nutrients determined from the measurement of the respiratory quotient	at day1
Secondary	Actimetry	Estimated ambulatory energy expenditure from heart rate	at day 1
Secondary	HGPO	Charges of blood insulin concentration, and glucose in response to oral glucose load	at day 1