Impact on the Proteolysis of Obesity in Dialysis (IPOD)
Recruitment status was Recruiting
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.
|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|
- 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 ]
- 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 ]
|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)|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01114789
|Contact: Patrick LACARIN||04 73 75 11 firstname.lastname@example.org|
|Clermont-Ferrand, France, 63003|
|Contact: Patrick LACARIN 04 73 75 11 95 email@example.com|
|Principal Investigator:||Yves BOIRIE, PUPH||CHU Clermont-Ferrand (CRNH)|