Impact on the Proteolysis of Obesity in Dialysis (IPOD)
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|ClinicalTrials.gov Identifier: NCT01114789|
Recruitment Status : Unknown
Verified January 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was: Recruiting
First Posted : May 3, 2010
Last Update Posted : January 26, 2011
|Condition or disease||Intervention/treatment||Phase|
|Hemodialysis Patients||Other: Proteolysis||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Impact on the Proteolysis of Obesity in Dialysis|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||March 2013|
- 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 ]
- 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 ]
- Resting energy metabolism will be measured by indirect calorimetry. [ Time Frame: 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). [ Time Frame: the day of the investigation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01114789
|Contact: Patrick LACARIN||04 73 75 11 email@example.com|
|Clermont-Ferrand, France, 63003|
|Contact: Patrick LACARIN 04 73 75 11 95 firstname.lastname@example.org|
|Principal Investigator:||Yves BOIRIE, PUPH||CHU Clermont-Ferrand (CRNH)|