Effect of Bariatric Surgery on Kidney Function
GAS
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 24, 2014
CompletedFirst Posted
Study publicly available on registry
May 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedSeptember 10, 2018
September 1, 2018
2.4 years
March 24, 2014
September 6, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change in accurately measured GFR
Up to 6 months and 18 months after surgery
Secondary Outcomes (5)
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
Change in 24hour blood pressure
Up to 6 months and 18 months after surgery
Change in arterial stiffness (as measured by sphygmocor)
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
Study Arms (1)
Bariatric surgery
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Male or female, older than 18 years of age
- Appointed to gastric by-pass surgery on Hvidovre Hospital, Denmark
You may not qualify if:
- Withdrawal of surgical indication
- Severe oedema or ascites
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Steno Diabetes Center Copenhagenlead
- Hvidovre University Hospitalcollaborator
Study Sites (1)
Peter Rossing
Gentofte Municipality, 2820, Denmark
Related Publications (1)
von Scholten BJ, Persson F, Svane MS, Hansen TW, Madsbad S, Rossing P. Effect of large weight reductions on measured and estimated kidney function. BMC Nephrol. 2017 Feb 6;18(1):52. doi: 10.1186/s12882-017-0474-0.
PMID: 28166744DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Rossing, Professor
Steno Diabetes Center Copenhagen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 24, 2014
First Posted
May 14, 2014
Study Start
March 1, 2014
Primary Completion
August 1, 2016
Study Completion
September 1, 2017
Last Updated
September 10, 2018
Record last verified: 2018-09