Informations générales (source: ClinicalTrials.gov)
Impact on the Proteolysis of Obesity in Dialysis (IPOD)
Interventional
N/A
University Hospital, Clermont-Ferrand (Voir sur ClinicalTrials)
janvier 2011
mars 2013
29 juin 2024
The objective of this study is to determine whether obesity has a protective effect on
muscle proteolysis in hemodialysis patients submitted to a short starvation. This effect
will be tested by comparing measuring muscle proteolysis, using regional infusion of a
tracer amino acid (D5 phenylalanine) in two groups of obese and non-obese patients
compared to obese and non-obese control subjects.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU Clermont-Ferrand - 63003 - Clermont-Ferrand - France | Patrick LACARIN | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Common Criteria for patients and healthy volunteers:
- Males and females.
- Age between 30 to 70 years.
- Body Mass Index:
Selection criteria for the obese: BMI> 30 kg/m2, Selection criteria for non-obese
subjects: 18.5 <BMI <25 kg/m2.
- Biological Review considered satisfactory by the investigator based on the topics
covered: chronic renal (obese or not) or healthy volunteers.
- Serology HIV and HCV negative.
- Subject giving his written informed consent
- Affiliated to National Health Insurance
Specific criteria for kidney chronic patients in hemodialysis:
- Patients on hemodialysis since more than 6 months.
- Patients with a clinical stable condition defined by the absence of progressive
disease.
Specific criteria for healthy volunteers:
- Subject considered as healthy after clinical examination and medical questionnaire
- Topic willing to be included in the national register of healthy volunteers.
- Common Criteria for patients and healthy volunteers:
- Males and females.
- Age between 30 to 70 years.
- Body Mass Index:
Selection criteria for the obese: BMI> 30 kg/m2, Selection criteria for non-obese
subjects: 18.5 <BMI <25 kg/m2.
- Biological Review considered satisfactory by the investigator based on the topics
covered: chronic renal (obese or not) or healthy volunteers.
- Serology HIV and HCV negative.
- Subject giving his written informed consent
- Affiliated to National Health Insurance
Specific criteria for kidney chronic patients in hemodialysis:
- Patients on hemodialysis since more than 6 months.
- Patients with a clinical stable condition defined by the absence of progressive
disease.
Specific criteria for healthy volunteers:
- Subject considered as healthy after clinical examination and medical questionnaire
- Topic willing to be included in the national register of healthy volunteers.
- Common Criteria for patients and healthy volunteers:
- Subject under 30 or over 70 years.
- Pregnant or lactating.
- For women of childbearing age: β-hCG assay positive and not have to contraceptives
reliable (oral contraceptive, IUD, implant or hormone patch).
- Medical or surgical history (judged by the investigator to be incompatible with the
study).
- Diabetics (type 1 or 2).
- Blood donation in the two months preceding the study.
- Special dietary needs (vegetarian, vegan, ...).
- Heavy alcohol consumption (> 2 to 3 glasses per day depending on sex) or presence of
an addiction.
- Tobacco significant (> 5 cigarettes / day or equivalent in cigars or pipe tobacco).
- Intense sporting activity (> 5 hours / week).
- Being in exclusion on the National Volunteers Data file
- Subjects deprived of their liberty by judicial or administrative.
Specific criteria for kidney chronic patients in hemodialysis:
- Patients treated with peritoneal dialysis.
- Patients treated with daily hemodialysis.
- Albuminemia <35 g / l and transthyrétinémie <300 mg / l
Specific criteria for healthy volunteers:
- Refusal to be registered on the National Volunteers Data file
- Currently participating or who having got 4500€ in this year before to have
participed in another clinical trial