Impact on the Proteolysis of Obesity in Dialysis (IPOD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Centre de Recherche en Nutrition Humaine d'Auvergne
Centre hospitalier de Vichy
AURA Auvergne Dialyse (Association pour l’Utilisation du Rein Artificiel Auvergne)
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01114789
First received: April 30, 2010
Last updated: January 25, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention
Hemodialysis Patients
Other: Proteolysis

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Impact on the Proteolysis of Obesity in Dialysis

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Fasting muscle protein kinetics will be assessed by the isotope dilution technique using D5 phenylalanine. The isotopic plasma enrichment in phenylalanine will be measured after collection of arterialized and venous blood of the forearm. [ Time Frame: 9h to 13h the day of the investigation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Whole-body protein metabolism will be assessed after 13C-leucine infusion in order to determine proteolysis, protein synthesis and protein balance, [ Time Frame: 9h to 13h the day of the investigation ] [ Designated as safety issue: Yes ]
  • Resting energy metabolism will be measured by indirect calorimetry. [ Time Frame: 10h to 11h and 12h to 12h40 the day of the investigation ] [ Designated as safety issue: Yes ]
  • Lipid metabolism will be investigated by measuring the participation of energy substrates to the energy expenditure, determination of plasma free fatty acids and calculation of VLDL synthesis rates (measuring the isotopic enrichment of apo B100). [ Time Frame: the day of the investigation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: January 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Proteolysis
    protocol designed to examine the effect of obesity on muscle proteolysis in hemodialysis and control
Detailed Description:

In hemodialysis patients, the risk of death decreases almost linearly as BMI increases, including in obese patients. Experimental data suggest that obesity may be associated with a reduction of muscle proteolysis during fasting.

In the hemodialysis patients, after an overnight fast an increased use of endogenous energy stores has been reported. The objective of the study is to evaluate the potentially "protective" effect of obesity on protein catabolism during short fasting periods.

Twenty non diabetic patients (men and women) on maintenance hemodialysis for more than six months, aged of 30 to 70 years, will be included: 10 obese (BMI ≥ 30) and 10 non obese patients (18.5 <BMI <25) will be compared with 20 healthy volunteers (men and women) aged 30 to 70 years, obese and non obese, according to the same criteria.

On the investigation day, tracer kinetic studies will be associated with resting energy expenditure measurements and body composition analysis (using dual energy x-ray absorptiometry (DXA).

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01114789

Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Centre de Recherche en Nutrition Humaine d'Auvergne
Centre hospitalier de Vichy
AURA Auvergne Dialyse (Association pour l’Utilisation du Rein Artificiel Auvergne)
Investigators
Principal Investigator: Yves BOIRIE, PUPH CHU Clermont-Ferrand (CRNH)
  More Information

No publications provided

Responsible Party: Patrick LACARIN, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01114789     History of Changes
Other Study ID Numbers: CHU-0071, 2008-A00729-46
Study First Received: April 30, 2010
Last Updated: January 25, 2011
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
chronic renal failure
hemodialysis
obesity
proteolysis

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014