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

U

University Hospital, Clermont-Ferrand

Status

Unknown

Conditions

Renal Failure

Treatments

Behavioral: Calorimetric chamber
Behavioral: automated DP

Study type

Interventional

Funder types

Other

Identifiers

NCT03347305
2015-A00035-44 (Other Identifier)
CHU-364

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 estimated patients

Sex

Male

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

24 participants in 2 patient groups

Patients Group DPA
Experimental group
Description:
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
Treatment:
Behavioral: automated DP
Healthy Volunteers
Experimental group
Description:
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
Treatment:
Behavioral: Calorimetric chamber

Trial contacts and locations

1

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Central trial contact

Patrick LACARIN

Data sourced from clinicaltrials.gov

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