Effect of Bariatric Surgery on Kidney Function (GAS)

September 6, 2018 updated by: Peter Rossing, Steno Diabetes Center Copenhagen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Gentofte, Denmark, 2820
        • Peter Rossing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bariatric surgery
Procedure: Gastric by-pass surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in accurately measured GFR
Time Frame: Up to 6 months and 18 months after surgery
Up to 6 months and 18 months after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Steno Diabetes Center Copenhagen

Collaborators

Hvidovre University Hospital

Investigators

  • Principal Investigator: Peter Rossing, Professor, Steno Diabetes Center Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

March 24, 2014

First Submitted That Met QC Criteria

May 12, 2014

First Posted (Estimate)

May 14, 2014

Study Record Updates

Last Update Posted (Actual)

September 10, 2018

Last Update Submitted That Met QC Criteria

September 6, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 3005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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