Morbid ObesityPhase 4LOKNCT01639677
Clinical Trial Between Laparoscopic Gastric Bypass and Laparoscopic Vertical Banded Gastroplasty for Morbid Obesity
A Phase 4 study testing Laparoscopic gastric bypass and Laparoscopic VBG in people with Morbid Obesity, run by Göteborg University at 1 site in Sweden.
Trial summary
This is a randomized clinical trial assessing the outcome of two surgical strategies to treat severe obesity; laparoscopic gastric bypass and laparoscopic VBG. Main outcome is weight loss and weight loss maintenance but other factors as body composition, eating pattern, metabolic normalisation, energy expenditure will… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Laparoscopic gastric bypass and Laparoscopic VBG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2000to Aug 2010
- Phase
- Phase 4
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI 35-50 kg/m2
- 20-60 y
Who cannot join
- Severe co-morbidity
- Unmotivated to long term follow up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial Between Laparoscopic Gastric Bypass and Laparoscopic Vertical Banded Gastroplasty for Morbid Obesity
This is a randomized clinical trial assessing the outcome of two surgical strategies to treat severe obesity; laparoscopic gastric bypass and laparoscopic VBG. Main outcome is weight loss and weight loss maintenance but other factors as body composition, eating pattern, metabolic normalisation, energy expenditure will also be assessed.
- Conditions
- Morbid Obesity
- Being tested
- Laparoscopic gastric bypass, Laparoscopic VBG
- Keywords
- Obesity, weight loss, surgery, gastric bypass, VBG
- Medical subject headings
- Obesity, Morbid, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic gastric bypassProcedure or surgery
Laparoscopic gastric bypass surgery
Laparoscopic VBGProcedure or surgery
Laparoscopic vertical banded gastroplasty
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic gastric bypass | Experimental | Not described Receives: Procedure: Laparoscopic gastric bypass |
| Laparoscopic VBG | Active comparator | Laparoscopic vertical banded gastroplasty Receives: Procedure: Laparoscopic VBG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Measured: 1, 2, 5 and 10 years after surgery
Secondary outcomes (4)
Body composition
Measured: 1, 2, 5 and 10 years after surgery
Eating pattern
Measured: 1, 2, 5 and 10 years after surgery
Energy expenditure
Measured: 1, 2, 5 and 10 years after surgery
Gut hormonal response
Measured: 4 and 10 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study startApr 2000
- Primary completionApr 2001
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London
- Responsible party
- Principal investigator, Torsten Olbers, Göteborg University
- Investigators
- Torsten Olbers, MD, PhD, Principal investigator, GöteborgU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01639677
- Sponsor's protocol ID
- LOK-2
- Acronym
- LOK
- Status last verified
- Jul 2012
- First submitted
- 22 Sep 2011
- Last updated
- 13 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Between Laparoscopic Gastric Bypass and Laparoscopic Vertical Banded Gastroplasty for Morbid Obesity
- ClinicalTrials.gov ID
- NCT01639677
- Acronym / sponsor ID
- LOK / LOK-2
- Conditions
- Morbid Obesity
- Keywords
- Obesity, weight loss, surgery, gastric bypass, VBG
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Imperial College London
- Study start
- Apr 2000
- Primary completion
- Apr 2001 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 13 Jul 2012 (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.
This is a randomized clinical trial assessing the outcome of two surgical strategies to treat severe obesity; laparoscopic gastric bypass and laparoscopic VBG. Main outcome is weight loss and weight loss maintenance but other factors as body composition, eating pattern, metabolic normalisation, energy expenditure will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic gastric bypass | Experimental | Procedure: Laparoscopic gastric bypass |
| Laparoscopic VBG | Active comparator | Procedure: Laparoscopic VBGLaparoscopic vertical banded gastroplasty |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI 35-50 kg/m2
- 20-60 y
Key exclusion criteria (2 listed)
- Severe co-morbidity
- Unmotivated to long term follow up
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 |
|---|---|---|
| Laparoscopic gastric bypassLaparoscopic gastric bypass surgery | Procedure or surgery | Laparoscopic gastric bypass |
| Laparoscopic VBGLaparoscopic vertical banded gastroplasty | Procedure or surgery | Laparoscopic VBG |
Primary outcome
Weight loss
Time frame: 1, 2, 5 and 10 years after surgery
4 secondary outcomes
Body composition
Time frame: 1, 2, 5 and 10 years after surgery
Eating pattern
Time frame: 1, 2, 5 and 10 years after surgery
Energy expenditure
Time frame: 1, 2, 5 and 10 years after surgery
Gut hormonal response
Time frame: 4 and 10 years 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 13 Jul 2012.
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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.
Torsten Olbers, MD, PhD principal investigator
GöteborgU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Laparoscopic gastric bypass and Laparoscopic VBG in people with Morbid Obesity, run by Göteborg University at 1 site in Sweden.
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 13 Jul 2012. 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 Sweden. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Weight loss (time frame: 1, 2, 5 and 10 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2012.