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.

Study Overview

• Status: Completed
• Conditions: Impaired Renal Function

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, W6 8RF
    • Charing Cross Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Obesity Surgery; Patients having gastric band, sleeve gastrectomy, and 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Glomerular Renal Function After Weight Loss Surgery as Measured by 51Cr-EDTA Clearance	The outcome measure is reported as the number of participants who achieved a change in the glomerular renal function after weight loss surgery as measured by 51Cr-EDTA Clearance. 51Cr-EDTA GFR was ascertained using bolus injection of 1.46-2.66 MBq 51Cr-EDTA, with between 6 and 8 venous blood samples were collected at approximately 15, 30, 60, 90, 120, 180, 240, and 300 min to assess 51Cr-EDTA clearance. 51Cr-EDTA GFR was calculated using the Bi-exponential Fitting Method described in the British Nuclear Medicine Society guidelines. The prepared standard and patient samples were counted for 15 and 60 mins respectively using a Wallac 1470 Wizard Gamma Counter (Perkin Elmer Inc., Waltham, Massachusetts, USA). The measured GFR was scaled to BSA in order to maintain uniformity in comparison to reported eGFR.	12 months

Collaborators and Investigators

• Sponsor: Imperial College London
• Investigators: Principal Investigator: Carel W le Roux, MBChB, PhD, Imperial College London

Publications and helpful links

General Publications

• Chuah LL, Miras AD, Perry LM, Frankel AH, Towey DJ, Al-Mayahi Z, Svensson W, le Roux CW. Measurement of glomerular filtration rate in patients undergoing obesity surgery. BMC Nephrol. 2018 Dec 29;19(1):383. doi: 10.1186/s12882-018-1188-7.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: January 6, 2012
• First Submitted That Met QC Criteria: January 9, 2012
• First Posted (Estimate): January 10, 2012

Study Record Updates

• Last Update Posted (Actual): November 19, 2020
• Last Update Submitted That Met QC Criteria: October 27, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: impaired renal function; sleeve gastrectomy; gastric bypass; gastric band; obesity related glmerulopathy; 51 Cr-EDTA clearance; GFR measurement
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Renal Insufficiency
• Other Study ID Numbers: BSR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO