Kidney Function Indexed Extracellular Volume Before and After Obesity Surgery
Measurement of Kidney Function Indexed Extracellular Volume Before and After Obesity Surgery in Kidney Patients With Severe Obesity or Massive
1 other identifier
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started May 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedFirst Posted
Study publicly available on registry
July 13, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJuly 13, 2016
July 1, 2016
1.2 years
May 12, 2015
July 8, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Ratio DFG / VEC
Average ratio DFG / VEC before and one year after gastric bypass
Month 12
Secondary Outcomes (2)
Albumin / urine creatinine
Month 12
GFR estimation formula
Month 12
Study Arms (1)
DFG mesure
OTHERMeasure the effect of gastric bypass on the report DFG / VEC
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Nice
Nice, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2015
First Posted
July 13, 2016
Study Start
May 1, 2015
Primary Completion
July 1, 2016
Study Completion
December 1, 2016
Last Updated
July 13, 2016
Record last verified: 2016-07