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Impact on the Proteolysis of Obesity in Dialysis (IPOD)

Primary Purpose

Hemodialysis Patients

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Proteolysis

About this trial

This is an interventional basic science trial for Hemodialysis Patients focused on measuring chronic renal failure, hemodialysis, obesity, proteolysis

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

CHU Clermont-FerrandRecruiting

Outcomes

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.

Secondary Outcome Measures

Whole-body protein metabolism will be assessed after 13C-leucine infusion in order to determine proteolysis, protein synthesis and protein balance,

Resting energy metabolism will be measured by indirect calorimetry.

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).

Full Information

NCT ID

NCT01114789

First Posted

April 30, 2010

Last Updated

January 25, 2011

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Centre de Recherche en Nutrition Humaine d'Auvergne, Centre Hospitalier de Vichy, AURA Auvergne Dialyse (Association pour l'Utilisation du Rein Artificiel Auvergne)

1. Study Identification

Unique Protocol Identification Number

NCT01114789

Brief Title

Impact on the Proteolysis of Obesity in Dialysis

Acronym

IPOD

Official Title

Impact on the Proteolysis of Obesity in Dialysis

Study Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Unknown status

Study Start Date

January 2011 (undefined)

Primary Completion Date

December 2012 (Anticipated)

Study Completion Date

March 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Centre de Recherche en Nutrition Humaine d'Auvergne, Centre Hospitalier de Vichy, AURA Auvergne Dialyse (Association pour l'Utilisation du Rein Artificiel Auvergne)

4. Oversight

5. Study Description

Brief Summary

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemodialysis Patients

Keywords

chronic renal failure, hemodialysis, obesity, proteolysis

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Other

Intervention Name(s)

Proteolysis

Intervention Description

protocol designed to examine the effect of obesity on muscle proteolysis in hemodialysis and control

Primary Outcome Measure Information:

Title

Time Frame

9h to 13h the day of the investigation

Secondary Outcome Measure Information:

Title

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

Title

Resting energy metabolism will be measured by indirect calorimetry.

Time Frame

10h to 11h and 12h to 12h40 the day of the investigation

Title

Time Frame

the day of the investigation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Patrick LACARIN

Phone

04 73 75 11 95

placarin@chu-clermontferrand.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yves BOIRIE, PUPH

Organizational Affiliation

CHU Clermont-Ferrand (CRNH)

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Clermont-Ferrand

City

Clermont-Ferrand

ZIP/Postal Code

63003

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Patrick LACARIN

Phone

04 73 75 11 95

placarin@chu-clermontferrand.fr

12. IPD Sharing Statement

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Impact on the Proteolysis of Obesity in Dialysis

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