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Effects of Obesity Surgery on Renal Function

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01507350
First Posted: January 10, 2012
Last Update Posted: August 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Carel Le Roux, Imperial College London
January 6, 2012
January 10, 2012
August 11, 2017
June 2011
June 1, 2017   (Final data collection date for primary outcome measure)
Changes in glomerular renal function after weight loss surgery as measured by 51Cr-EDTA Clearance [ Time Frame: 12 months ]
GFR assessment using the abbreviated and extended MDRD formulae, CCG and the 51Chromium-EDTA clearance.
Same as current
Complete list of historical versions of study NCT01507350 on ClinicalTrials.gov Archive Site
  • Microalbuminuria, creatinine clearance, Cystatin C. [ Time Frame: 12 months ]
    Compare different ways of measuring renal function after weight loss surgery.
  • Differences in alterations in renal function dependent on the used surgical procedure. [ Time Frame: 12 months ]
    Compare the renal function among the three different surgical cohorts, namely gastric bypass, gastric band, and sleeve gastrectomy.
Same as current
Not Provided
Not Provided
 
Effects of Obesity Surgery on Renal Function
Effects of Obesity Surgery on Renal Function

Increasing risk of impaired renal function as a result of obesity is well known. Early data has postulated that weight loss might improve kidney function, but the evidence is rather limited due to the difficulties in measuring glomerular filtration rate(GFR) after weight loss. Cystatin C, GFR measurement using Cockcroft-Gault (CCG) and Modification of Diet in Renal Disease (MDRD) equations, have all yield conflicting results after weight loss surgery.

The study aim to assess:

  1. use of 51Cr-EDTA Clearance as the methodological gold standard in evaluating changes in renal function before and after weight loss surgery.
  2. the reliability of using MDRD, CCG and Cystatin C in measuring GFR after weight loss surgery
  3. the differences in alterations in renal function dependent on the surgical procedures( gastric bypass, gastric band, sleeve gastrectomy).
  4. the use of urine albumin/creatinine ratio in detecting alterations in microalbuminuria.

This is a prospective study on obese human subjects undergoing bariatric surgery. Forty-five patients due to undergo gastric bypass (n=15), gastric banding (n=15), and gastric sleeve surgery (n=15) will be recruited.

Subjects will be screened prior to entry into the study with full history, examination, routine bloods (FBC, U+E, liver function tests, and glucose).

  1. Blood samples and 24h urine specimens are taken at four time points: preoperatively as well 6 weeks, 6 and 12 months postoperatively.
  2. The following methods of GFR assessment will be executed the same time point: measurement of serum creatinine concentration, calculation of the abbreviated and extended MDRD formulae, CCG, creatinine clearance, serum Cystatin C concentration and the 51Chromium-EDTA clearance.

Inclusion criteria

  1. Patients with a BMI of >35kg/m2 approved for obesity surgery based on the NICE criteria.
  2. Patients with a GFR <60 mL/min/1.73

Exclusion criteria

1. Allergy to chromium

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
  1. Patients with a BMI of >35kg/m2 approved for obesity surgery based on the NICE criteria.
  2. Patients with a GFR <60 mL/min/1.73 m2
Impaired Renal Function
Not Provided
  • gastric band
    Patients having gastric band will have blood and urine tests, and 51 Cr-EDTA clearance to assess renal function. These are taken before and after the surgery at 6 weeks , 6 months and 12 months.
  • sleeve gastrectomy
    Patients having sleeve gastrectomy will have blood and urine tests, and 51 Cr-EDTA clearance to assess renal function. These are taken before and after the surgery at 6 weeks , 6 months and 12 months.
  • gastric bypass
    Patients having gastric bypass will have blood and urine tests, and 51 Cr-EDTA clearance to assess renal function. These are taken before and after the surgery at 6 weeks , 6 months and 12 months.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
August 1, 2017
June 1, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with a BMI of >35kg/m2 approved for obesity surgery based on the NICE criteria.
  • Patients with a GFR <60 mL/min/1.73 m2

Exclusion Criteria:

  • Allergy to chromium
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01507350
BSR
Yes
Not Provided
Plan to Share IPD: No
Carel Le Roux, Imperial College London
Imperial College London
Not Provided
Principal Investigator: Carel W le Roux, MBChB, PhD Imperial College London
Imperial College London
August 2017