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Kidney Function Indexed Extracellular Volume Before and After Obesity Surgery

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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
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Brief Summary:

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

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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

Arm Intervention/treatment
DFG mesure
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.




Primary Outcome Measures :
  1. Ratio DFG / VEC [ Time Frame: Month 12 ]
    Average ratio DFG / VEC before and one year after gastric bypass


Secondary Outcome Measures :
  1. Albumin / urine creatinine [ Time Frame: Month 12 ]
  2. 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 )



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Topic GFR estimated by having the simplified formula of MDRD <60 ml / min / 1.73 m²
  • Topic with BMI ≥ 40 kg / m², or ≥ 35 kg / m²
  • Subject having at least one comorbidity could be improved after surgery after failure of medical treatment: hypertension , OSAHS and other severe respiratory disorders, severe metabolic disorders, particularly type 2 diabetes , debilitating musculoskeletal diseases, steatohepatitis nonalcoholic .
  • Topic who signed the informed consent
  • Topic affiliated to the social security
  • Male or female Topics
  • Elderly 18 to 70 inclusive

Exclusion Criteria:

  • Non- Caucasian person because the necessary correction factors and not always available for the formula to estimate GFR ( Cockcroft , Salazar and Corcoran ) .
  • No major under guardianship
  • Nobody hospitalized without his consent and not protected by law
  • Private person of liberty
  • Pregnant Woman, knowing that a pregnancy test will be performed for women of childbearing age . Results will be communicated to the patient by a doctor of his choice.
  • Rapidly progressive glomerulonephritis
  • Nephrotic proteinuria ranking

Information from the National Library of Medicine

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


Contacts
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Contact: Guillaume FAVRE favre.g@chu-nice.fr

Locations
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France
CHU de Nice Recruiting
Nice, France
Contact: Guillaume FAVRE       favre.g@chu-nice.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice

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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT02830646    
Other Study ID Numbers: 14-AOI-09
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms