Effects of Obesity Surgery on Renal Function

NCT01507350 | Completed Results DMC

• 1 other identifier: BSR
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Impaired Renal Function

Keywords

obesity related glmerulopathy; 51 Cr-EDTA clearance; impaired renal function; gastric band; GFR measurement; gastric bypass; sleeve gastrectomy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Allergy to chromium

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 30594245 DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Carel le Roux
• Organization: Imperial College

c.leroux@imperial.ac.uk

07970719453

Study Officials

• Carel W le Roux, MBChB, PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant metabolic medicine

Study Record Dates

• First Submitted: January 6, 2012
• First Posted: January 10, 2012
• Study Start: June 1, 2011
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2016
• Last Updated: November 19, 2020
• Results First Posted: October 20, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)