Obese Subjects Who Will Undergo Gastric By-pass SurgeryGASNCT02138565
Effect of Bariatric Surgery on Kidney Function
A study testing Gastric by-pass surgery in people with Obese Subjects Who Will Undergo Gastric By-pass Surgery, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial 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)). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obese Subjects Who Will Undergo Gastric By-pass Surgery
- What is being tested?
- Gastric by-pass surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2014to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, older than 18 years of age
- Appointed to gastric by-pass surgery on Hvidovre Hospital, Denmark
Who cannot join
- Withdrawal of surgical indication
- Severe oedema or ascites
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Gastric by-pass surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric by-pass surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Bariatric surgery | Experimental | Not described Receives: Procedure: Gastric by-pass surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in accurately measured GFR
Measured: 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).
Measured: Up to 6 months and 18 months after surgery
Change in 24hour blood pressure
Measured: Up to 6 months and 18 months after surgery
Change in arterial stiffness (as measured by sphygmocor)
Measured: Up to 6 months and 18 months after surgery
Change in body composition, as measured by Dual-energy X-ray absorptiometry scan (DXA-scan)
Measured: Up to 6 months and 18 months after surgery
Change in accurately measured GFR compared with change in estimated GFR
Measured: Up to 6 months and 18 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2016
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obese Subjects Who Will Undergo Gastric By-pass SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital
- Responsible party
- Principal investigator, Peter Rossing, Steno Diabetes Center Copenhagen
- Investigators
- Peter Rossing, Professor, Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138565
- Sponsor's protocol ID
- 3005
- Acronym
- GAS
- Status last verified
- Sep 2018
- First submitted
- 24 Mar 2014
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28166744
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bariatric Surgery on Kidney Function
- ClinicalTrials.gov ID
- NCT02138565
- Acronym / sponsor ID
- GAS / 3005
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital
- Study start
- Mar 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 14 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bariatric surgery | Experimental | Procedure: Gastric by-pass surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female, older than 18 years of age
- Appointed to gastric by-pass surgery on Hvidovre Hospital, Denmark
Key exclusion criteria (2 listed)
- Withdrawal of surgical indication
- Severe oedema or ascites
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric by-pass surgery | Procedure or surgery | Bariatric surgery |
Primary outcome
Change in accurately measured GFR
Time frame: Up to 6 months and 18 months after surgery
5 secondary outcomes
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
Change in 24hour blood pressure
Time frame: 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
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
Change in accurately measured GFR compared with change in estimated GFR
Time frame: Up to 6 months and 18 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- Derived from this study: PubMed 28166744von 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Rossing, Professor principal investigator
Steno Diabetes Center Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric by-pass surgery in people with Obese Subjects Who Will Undergo Gastric By-pass Surgery, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in accurately measured GFR (time frame: Up to 6 months and 18 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02138565, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2018.