Obese Subjects Who Will Undergo Gastric By-pass Surgery Clinical Trial
— GASOfficial title:
Effect of Bariatric Surgery on Kidney Function
| NCT number | NCT02138565 |
| Other study ID # | 3005 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 2014 |
| Est. completion date | September 2017 |
| Verified date | September 2018 |
| Source | Steno Diabetes Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | September 2017 |
| Est. primary completion date | August 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Peter Rossing | Gentofte |
| Lead Sponsor | Collaborator |
|---|---|
| Steno Diabetes Center | Hvidovre University Hospital |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in accurately measured GFR | Up to 6 months and 18 months after surgery | ||
| Secondary | 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 | ||
| Secondary | Change in 24hour blood pressure | Up to 6 months and 18 months after surgery | ||
| Secondary | Change in arterial stiffness (as measured by sphygmocor) | Up to 6 months and 18 months after surgery | ||
| Secondary | Change in body composition, as measured by Dual-energy X-ray absorptiometry scan (DXA-scan) | Up to 6 months and 18 months after surgery | ||
| Secondary | Change in accurately measured GFR compared with change in estimated GFR | Up to 6 months and 18 months after surgery |