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Effect of Bariatric Surgery on Kidney Function (GAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02138565
Recruitment Status : Completed
First Posted : May 14, 2014
Last Update Posted : September 10, 2018
Sponsor:
Collaborator:
Hvidovre University Hospital
Information provided by (Responsible Party):
Peter Rossing, 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.


Condition or disease Intervention/treatment Phase
Obese Subjects Who Will Undergo Gastric By-pass Surgery Procedure: Gastric by-pass surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Bariatric Surgery on Kidney Function
Study Start Date : March 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bariatric surgery Procedure: Gastric by-pass surgery



Primary Outcome Measures :
  1. Change in accurately measured GFR [ Time Frame: Up to 6 months and 18 months after surgery ]

Secondary Outcome Measures :
  1. 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 ]
  2. Change in 24hour blood pressure [ Time Frame: Up to 6 months and 18 months after surgery ]
  3. Change in arterial stiffness (as measured by sphygmocor) [ Time Frame: Up to 6 months and 18 months after surgery ]
  4. 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 ]
  5. Change in accurately measured GFR compared with change in estimated GFR [ Time Frame: Up to 6 months and 18 months after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138565


Locations
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Denmark
Peter Rossing
Gentofte, Denmark, 2820
Sponsors and Collaborators
Steno Diabetes Center Copenhagen
Hvidovre University Hospital
Investigators
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Principal Investigator: Peter Rossing, Professor Steno Diabetes Center Copenhagen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Peter Rossing, Professor, Steno Diabetes Center Copenhagen
ClinicalTrials.gov Identifier: NCT02138565    
Other Study ID Numbers: 3005
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018