Measurement of the Energy Metabolism of Peritoneal Dialysis Patients

NCT ID: NCT03347305

Last Updated: 2019-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-01

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Renal Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

No masking

Study Groups

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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

Group Type EXPERIMENTAL

automated DP

Intervention Type BEHAVIORAL

Energy expenditure measurement

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

Group Type EXPERIMENTAL

Calorimetric chamber

Intervention Type BEHAVIORAL

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

Interventions

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automated DP

Energy expenditure measurement

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pôle Santé République

OTHER

Sponsor Role collaborator

Service de Néphrologie et Hémodialyse

UNKNOWN

Sponsor Role collaborator

Jacques Lacarin Hospital Center

OTHER

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julien ANIORT

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Patrick LACARIN

Role: CONTACT

0473751195

Facility Contacts

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Patrick LACARIN

Role: primary

0473751195

Other Identifiers

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2015-A00035-44

Identifier Type: OTHER

Identifier Source: secondary_id

CHU-364

Identifier Type: -

Identifier Source: org_study_id

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