Impact on the Proteolysis of Obesity in Dialysis

Hemodialysis Patients Clinical Trial

— IPOD  

Official title:

Impact on the Proteolysis of Obesity in Dialysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01114789
• Other study ID #: CHU-0071
• Secondary ID: 2008-A00729-46
• Status: Recruiting
• Phase: N/A
• First received: April 30, 2010
• Last updated: January 25, 2011
• Start date: January 2011
• Est. completion date: March 2013

Study information

• Verified date: January 2011
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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: ß-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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hemodialysis Patients

Intervention

Other:
• Proteolysis
protocol designed to examine the effect of obesity on muscle proteolysis in hemodialysis and control

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	AURA Auvergne Dialyse (Association pour l’Utilisation du Rein Artificiel Auvergne), Centre de Recherche en Nutrition Humaine d'Auvergne, Centre hospitalier de Vichy

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		9h to 13h the day of the investigation	Yes
Secondary	Whole-body protein metabolism will be assessed after 13C-leucine infusion in order to determine proteolysis, protein synthesis and protein balance,		9h to 13h the day of the investigation	Yes
Secondary	Resting energy metabolism will be measured by indirect calorimetry.		10h to 11h and 12h to 12h40 the day of the investigation	Yes
Secondary	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).		the day of the investigation	Yes