Impact on the Proteolysis of Obesity in Dialysis

NCT01114789 | Unknown

• 2 other identifiers: CHU-00712008-A00729-46
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis Patients

Keywords

chronic renal failure; hemodialysis; obesity; proteolysis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

• Resting energy metabolism will be measured by indirect calorimetry.

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

• 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

Interventions

Proteolysis OTHER

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

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Centre de Recherche en Nutrition Humaine d'Auvergne: collaborator
• Centre Hospitalier de Vichy: collaborator
• AURA Auvergne Dialyse (Association pour l'Utilisation du Rein Artificiel Auvergne): collaborator

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic; Obesity

Interventions

Proteolysis

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biochemical Phenomena; Chemical Phenomena; Metabolism

Study Officials

• Yves BOIRIE, PUPH

  CHU Clermont-Ferrand (CRNH)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95; placarin@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 30, 2010
• First Posted: May 3, 2010
• Study Start: January 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: January 26, 2011

Record last verified: 2011-01

Locations

FR (1)