Effects of Obesity Surgery on Renal Function

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2016-08-01

Brief Summary

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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.

Detailed Description

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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

Conditions

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Impaired Renal Function

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Carel Le Roux

Consultant metabolic medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carel W le Roux, MBChB, PhD

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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Charing Cross Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED

PMID: 30594245 (View on PubMed)

Other Identifiers

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BSR

Identifier Type: -

Identifier Source: org_study_id