Mätning av energimetabolismen hos patienter med peritonealdialys (CALIMERO 2)
Studie i kalorimetrisk rum av energimetabolismen hos patienter med nedsatt njurfunktion som behandlas med automatiserad peritonealdialys
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Clermont-Ferrand, Frankrike, 63003
- CHU Clermont-Ferrand
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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 |
Energy expenditure measurement |
|
Experimentell: 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 |
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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Energy expenditure measured by indirect calorimetry in a calorimetric chamber
Tidsram: at day 1
|
Energy expenditure measured by indirect calorimetry in a calorimetric chamber |
at day 1
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
respiratory quotient (RQ)
Tidsram: at day1
|
Nature of the oxidized nutrients determined from the measurement of the respiratory quotient |
at day1
|
|
Actimetry
Tidsram: at day 1
|
Estimated ambulatory energy expenditure from heart rate |
at day 1
|
|
HGPO
Tidsram: at day 1
|
Charges of blood insulin concentration, and glucose in response to oral glucose load |
at day 1
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Julien ANIORT, University Hospital, Clermont-Ferrand
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CHU-364
- 2015-A00035-44 (Annan identifierare: 2015-A00035-44)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .