Severe ObesityBMI>50NCT02033577
Effects of Long Biliopancreatic Limb Versus Long Alimentary Limb in Superobesity, a Randomized Study
A study testing Distal gastrojejunal bypass and RYGB in people with Severe Obesity, run by Aleris Obesity at 1 site in Sweden.
Trial summary
Surgical bypassing of a longer section of the small bowel (when doing a gastric bypass operation) gives better results on body weight in the superobese. We do not yet know whether it is beneficial to exclude more of the proximal small bowel or more of the distal. Side effects of bypassing can also be different. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Severe Obesity
- What is being tested?
- Distal gastrojejunal bypass and RYGB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2011to Aug 2016
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI > 50
Who cannot join
- Psychiatric disease
- Inflammatory bowel disease
- inability to understand Swedish
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Aleris Obesity
Lund
Bent Johnny Nergaard, MD, +4792861730, bjnergard@me.com
Jan Hedenbro
About this study
Official title: Effects of Long Biliopancreatic Limb vs Long Alimentary Limb in Superobesity
Surgical bypassing of a longer section of the small bowel (when doing a gastric bypass operation) gives better results on body weight in the superobese. We do not yet know whether it is beneficial to exclude more of the proximal small bowel or more of the distal. Side effects of bypassing can also be different.
Study aims at clarifying possible differences in effects and side-effects of these two surgical-technical variations.
Read the detailed description
Randomisation in the OR between long biliopancreatic limb and long alimentary limb. GAstric component identical.
Perioperative biopsies to assess mucosal properties at the gastrojejunostomy and the enteroanastomosis. Repeat biopsies (gastroscopy) at one year to identify changes in the mucosa at the Gastroenteroanastomosis.
- Conditions
- Severe Obesity
- Being tested
- Distal gastrojejunal bypass, RYGB
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distal gastrojejunal bypassProcedure or surgery
RYGB with 200 cm BP limb and 150 cm common limb, effect on EWL, QoL and complications
RYGBProcedure or surgery
RYGB with 60 cm BP limb and 150 cm alimentary limb, effect on
| Study group | Role | What they receive |
|---|---|---|
| Distal gastrojejunal bypass | Experimental | RYGB with 200 cm BP limb and 150 cm common limb Receives: Procedure: Distal gastrojejunal bypass |
| RYGB | Active comparator | RYGB with 60 cm BP limb and 150 cm alimentary limb Receives: Procedure: RYGB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight reduction
Body weight reduction is currently the best substitute endpoint to correlate with the hard endpopints such as death, comorbidities etc.
Measured: 2 years from end of inclusion
Secondary outcomes (1)
Patient assessed quality of life
We employ SF-36, Op-9, GSRS, TFEQ scales
Measured: 2 years from end of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startAug 2011
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aleris Obesity
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lund University
- Responsible party
- Principal investigator, Jan Hedenbro, Aleris Obesity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033577
- Sponsor's protocol ID
- NCT01514799
- Acronym
- BMI>50
- Status last verified
- Mar 2015
- First submitted
- 9 Jan 2014
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Long Biliopancreatic Limb vs Long Alimentary Limb in Superobesity
- ClinicalTrials.gov ID
- NCT02033577
- Acronym / sponsor ID
- BMI>50 / NCT01514799
- Conditions
- Severe Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Aleris ObesityIndustry (pharma, biotech, devices)
- Collaborators
- Lund University
- Study start
- Aug 2011
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 13 Jan 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.
Surgical bypassing of a longer section of the small bowel (when doing a gastric bypass operation) gives better results on body weight in the superobese. We do not yet know whether it is beneficial to exclude more of the proximal small bowel or more of the distal. Side effects of bypassing can also be different.
Study aims at clarifying possible differences in effects and side-effects of these two surgical-technical variations.
Detailed description
Randomisation in the OR between long biliopancreatic limb and long alimentary limb. GAstric component identical.
Perioperative biopsies to assess mucosal properties at the gastrojejunostomy and the enteroanastomosis. Repeat biopsies (gastroscopy) at one year to identify changes in the mucosa at the Gastroenteroanastomosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Distal gastrojejunal bypass | Experimental | Procedure: Distal gastrojejunal bypassRYGB with 200 cm BP limb and 150 cm common limb |
| RYGB | Active comparator | Procedure: RYGBRYGB with 60 cm BP limb and 150 cm alimentary limb |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI > 50
Key exclusion criteria (3 listed)
- Psychiatric disease
- Inflammatory bowel disease
- inability to understand Swedish
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 |
|---|---|---|
| Distal gastrojejunal bypassRYGB with 200 cm BP limb and 150 cm common limb, effect on EWL, QoL and complications | Procedure or surgery | Distal gastrojejunal bypass |
| RYGBRYGB with 60 cm BP limb and 150 cm alimentary limb, effect on | Procedure or surgery | RYGB |
Primary outcome
Body weight reduction
Time frame: 2 years from end of inclusion
Body weight reduction is currently the best substitute endpoint to correlate with the hard endpopints such as death, comorbidities etc.
1 secondary outcome
Patient assessed quality of life
Time frame: 2 years from end of inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distal gastrojejunal bypass and RYGB in people with Severe Obesity, run by Aleris Obesity 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 17 Mar 2015. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Hedenbro, MD,PhD (+46705132572, jan.hedenbro@aleris.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight reduction (time frame: 2 years from end of inclusion). 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 17 Mar 2015.