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OpenTrials
Completed

NCT Number: NCT02138565

Effect of Bariatric Surgery on Kidney Function

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.

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Key information

Conditions

Obese Subjects Who Will Undergo Gastric By-pass Surgery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peter Rossing

Gentofte Municipality, 2820, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gastric by-pass surgery

Procedure

Primary outcomes

  1. Change in accurately measured GFR

    Time frame: Up to 6 months and 18 months after surgery

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Steno Diabetes Center Copenhagen

Other

Collaborators

  • Hvidovre University Hospital

Registry information

Acronym: GAS

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
May 14, 2014
Registry last updated
Sep 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.