Effect of Bariatric Surgery on Kidney Function

Not Applicable

Completed

• Conditions: Obese Subjects Who Will Undergo Gastric By-pass Surgery
• Interventions: Procedure: Gastric by-pass surgery

• Registration Number: NCT02138565
• Lead Sponsor: Steno Diabetes Center Copenhagen

Brief Summary

Primary hypothesis:

A large reduction in weight is not associated with a change in accurately measured glomerular filtration rate (GFR) (51Chromium ethylenediaminetetraacetic acid plasma clearance (51Cr-EDTA)).

Secondary hypothesis:

A large reduction in weight is associated with a greater change in estimated GFR (The Modification of Diet in Renal Disease (MDRD-formula)) than in accurately measured GFR.

Other formulas for estimated GFR (Cockcroft Gault, Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), CKD-EPI with cystatin C) are better correlated with accurately measured GFR.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-24
• Study First Submitted QC: 2014-05-12
• Study First Posted: 2014-05-14
• Primary Completion: 2016-08
• Study Completion: 2017-09
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-06
• Last Update Posted: 2018-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Male or female, older than 18 years of age
• Appointed to gastric by-pass surgery on Hvidovre Hospital, Denmark

Exclusion Criteria

• Withdrawal of surgical indication
• Severe oedema or ascites

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bariatric surgery	Gastric by-pass surgery	-

Primary Outcome Measures

Name	Time	Method
Change in accurately measured GFR	Up to 6 months and 18 months after surgery

Secondary Outcome Measures

Name	Time	Method
Change in arterial stiffness (as measured by sphygmocor)	Up to 6 months and 18 months after surgery
Change in 24hour blood pressure	Up to 6 months and 18 months after surgery
Change in body composition, as measured by Dual-energy X-ray absorptiometry scan (DXA-scan)	Up to 6 months and 18 months after surgery
Change in accurately measured GFR compared with change in estimated GFR	Up to 6 months and 18 months after surgery
Change in estimated GFR (as measured by the MDRD formula, the Cockcroft Gault formula, CKD-EPI formula and CKD-EPI with cystatin C formula).	Up to 6 months and 18 months after surgery

Trial Locations

Locations (1)

Peter Rossing; 🇩🇰 Gentofte, Denmark