Kidney Function Indexed Extracellular Volume Before and After Obesity Surgery

Obesity Clinical Trial

Official title:

Measurement of Kidney Function Indexed Extracellular Volume Before and After Obesity Surgery in Kidney Patients With Severe Obesity or Massive

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02830646
• Other study ID #: 14-AOI-09
• Status: Recruiting
• Phase: N/A
• First received: May 12, 2015
• Last updated: July 8, 2016
• Start date: May 2015
• Est. completion date: December 2016

Study information

• Verified date: July 2016
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Guillaume FAVRE
• Email: favre.g[@]chu-nice.fr
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: December 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• DFG mesure
Measure the effect of gastric bypass on the report DFG / VEC.

Locations

Country	Name	City	State
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio DFG / VEC	Average ratio DFG / VEC before and one year after gastric bypass	Month 12	No
Secondary	Albumin / urine creatinine		Month 12	No
Secondary	GFR estimation formula	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 )	Month 12	No