Kidney Function Indexed Extracellular Volume Before and After Obesity Surgery

July 8, 2016 updated by: Centre Hospitalier Universitaire de Nice

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ratio DFG / VEC
Time Frame: Month 12
Average ratio DFG / VEC before and one year after gastric bypass
Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Albumin / urine creatinine
Time Frame: Month 12
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 )
Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (ANTICIPATED)

July 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

May 12, 2015

First Submitted That Met QC Criteria

July 8, 2016

First Posted (ESTIMATE)

July 13, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

July 13, 2016

Last Update Submitted That Met QC Criteria

July 8, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-AOI-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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