Kidney Function Indexed Extracellular Volume Before and After Obesity Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02830646|
Recruitment Status : Unknown
Verified July 2016 by Centre Hospitalier Universitaire de Nice.
Recruitment status was: Recruiting
First Posted : July 13, 2016
Last Update Posted : July 13, 2016
Obesity promotes chronic kidney disease and is accelerating its shift to the stage of renal replacement. Bariatric surgery is a treatment for severe or morbid obesity whose renal benefit is currently unknown. The glomerular filtration rate (GFR) is the best parameter to define the kidney function. It can be estimated using formulas by assaying endogenous markers (creatinine, cystatin C) or measured with an exogenous tracer glomerular filtration (51 Cr-EDTA).
Bariatric surgery alters the production of endogenous markers and the extracellular volume (VEC) with 2 important consequences on the assessment of GFR: the formula to estimate GFR is not possible to compare renal function before and after surgery because of the variation in production of endogenous glomerular filtration markers in the same subject; decreasing VEC predicted decreased GFR after surgery, since these parameters are in part proportional to each other.
Our working hypothesis is that bariatric surgery protects the kidneys of patients with chronic kidney disease. To demonstrate this, investigators propose to compare the ratio DFG / VEC before and after gastric bypass.
Goals The main objective is to measure the effect of gastric bypass on the report DFG / VEC. Secondary objectives are to assess the effect of gastric bypass on the albumin / urine creatinine and evaluate the performance of the main GFR estimating formulas in people with severe or morbid obesity.
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Other: DFG mesure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Measurement of Kidney Function Indexed Extracellular Volume Before and After Obesity Surgery in Kidney Patients With Severe Obesity or Massive|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||December 2016|
Measure the effect of gastric bypass on the report DFG / VEC
Other: DFG mesure
Measure the effect of gastric bypass on the report DFG / VEC.
- Ratio DFG / VEC [ Time Frame: Month 12 ]Average ratio DFG / VEC before and one year after gastric bypass
- Albumin / urine creatinine [ Time Frame: Month 12 ]
- GFR estimation formula [ Time Frame: Month 12 ]GFR using the Cockcroft formulas , Salazar and Corcoran , simplified MDRD and CKD -EPI . Each of GFR estimation formula , we calculate the mean bias by the difference between the estimated value and the measured value and the percentage of patients with the value obtained by estimation is between -25 % and + 25 % in value measured ( awerage Within 50 or AW50 )
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): NCT02830646
|Contact: Guillaume FAVREemail@example.com|
|CHU de Nice||Recruiting|
|Contact: Guillaume FAVRE firstname.lastname@example.org|