Kidney Function Indexed Extracellular Volume Before and After Obesity Surgery

NCT ID: NCT02830646

Last Updated: 2016-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-12-31

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.

Conditions

Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

DFG mesure

Measure the effect of gastric bypass on the report DFG / VEC

Group Type: OTHER

DFG mesure

Intervention Type: OTHER

Measure the effect of gastric bypass on the report DFG / VEC.

Interventions

DFG mesure

Measure the effect of gastric bypass on the report DFG / VEC.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Nice

Nice, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Guillaume FAVRE

Role: CONTACT

favre.g@chu-nice.fr

Facility Contacts

Guillaume FAVRE

Role: primary

favre.g@chu-nice.fr

Other Identifiers

14-AOI-09

Identifier Type: -

Identifier Source: org_study_id