Morbid ObesityNCT01514799
Effects of Long Biliopancreatic Limb vs. Long Alimentary Limb in Superobesity, a Randomized Study
A study testing gastric bypass in people with Morbid Obesity and Weight Loss, run by Aleris Obesity at 1 site in Sweden.
Trial summary
Super Obesity, i.e. a BMI above 50, is difficult to treat. Normal gastric bypass surgery is not always enough for proper weight control. Bypassing a longer segment of the gut may be more beneficial. Which part to bypass is not clear. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Morbid Obesity, Weight Loss
- What is being tested?
- gastric bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSweden
- Study dates
- 29 Aug 2011to 1 Feb 2020
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI 50-65
- Age 18-55
- Conservative attempts at weight reduction failed
Who cannot join
- Inability to speak and understand the Swedish language
- Residence outside the county of Skåne
- Psychotic disease
- Inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Study Comparing the Effects of Gastric Bypass Using a Long BP-limb vs. a Long Alimentary Limb in Morbid Obesity
Super Obesity, i.e. a BMI above 50, is difficult to treat. Normal gastric bypass surgery is not always enough for proper weight control. Bypassing a longer segment of the gut may be more beneficial. Which part to bypass is not clear.
The investigators want to compare the effects between preventing a 60 cm proximal (oral) portion of the jejunum from food contact with the effects when preventing a 200 cm part of the jejunum from contact with bile and pancreatic juice.
Endpoints are quality of life, gastrointestinal function, and weight development.
Read the detailed description
Two variations of gastric bypass are compared:
Method 1 (test method):A 200 cm BP-limb (distance Treitz to EA) + 150 cm common channel (EA to ileocecal valve) + Roux-Y-limb variable Method 2 (standard method): A 60 cm BP limb + 150 cm Roux-Y-limb + common channel variable.
Patients are evaluated according to the principles of the Scandinavian Obesity surgery registry (SOReg) with the addition of two additional questionnaires.
FU time is set at 5 years.
- Conditions
- Morbid Obesity, Weight Loss
- Being tested
- gastric bypass
- Keywords
- gastric bypass, morbid obesity, gut function, weight loss
- Medical subject headings
- Obesity, Morbid, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastric bypassProcedure or surgery
two techniques of gastric bypass for studying the effects of making a long BP-limb
| Study group | Role | What they receive |
|---|---|---|
| standard length bp limb, long alimentary limb | Active comparator | our normal way of doing a gastric bypass 60 cm BP limb Receives: Procedure: gastric bypass |
| Long BP limb | Experimental | 200 cm BP limb Receives: Procedure: gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
body weight reduction
absolute BW reduction, percentage of patients reaching BMI below 30,
Measured: 5 years
Secondary outcomes (1)
gastrointestinal function
SF-36, Op-9, GSRS and TFEQ are used in patient assessed variables
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2012 (estimated)
- Study start29 Aug 2011
- Primary completion20 Nov 2015
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Morbid 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
- Model description
- Randomised study between long and standard biliopancreatic limb in gstric bypass surgery
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aleris Obesity
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan L Hedenbro, Principal investigator, Lunds Universitets Diabetescentrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514799
- Sponsor's protocol ID
- 2011_HG_Aleris_limb_length
- Status last verified
- Feb 2020
- First submitted
- 18 Jan 2012
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Nergard BJ, Leifson BG, Gislason H, Hedenbro JL. Effect of different limb lengths on quality of life, eating patterns and gastrointestinal symptoms after Roux-en-Y gastric bypass in superobese patients: randomized study. BJS Open. 2020 Sep 15;4(6):1109-16. doi: 10.1002/bjs5.50334. Online ahead of print.
PubMed 32931641Nergard BJ, Lindqvist A, Gislason HG, Groop L, Ekelund M, Wierup N, Hedenbro JL. Mucosal glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide cell numbers in the super-obese human foregut after gastric bypass. Surg Obes Relat Dis. 2015 Nov-Dec;11(6):1237-46. doi: 10.1016/j.soard.2015.03.021. Epub 2015 Apr 2.
PubMed 26143297
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study Comparing the Effects of Gastric Bypass Using a Long BP-limb vs. a Long Alimentary Limb in Morbid Obesity
- ClinicalTrials.gov ID
- NCT01514799
- Acronym / sponsor ID
- 2011_HG_Aleris_limb_length
- Conditions
- Morbid Obesity, Weight Loss
- Keywords
- gastric bypass, morbid obesity, gut function, weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Aleris ObesityIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2011 (actual)
- Primary completion
- 20 Nov 2015 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 23 Jan 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.
Super Obesity, i.e. a BMI above 50, is difficult to treat. Normal gastric bypass surgery is not always enough for proper weight control. Bypassing a longer segment of the gut may be more beneficial. Which part to bypass is not clear.
The investigators want to compare the effects between preventing a 60 cm proximal (oral) portion of the jejunum from food contact with the effects when preventing a 200 cm part of the jejunum from contact with bile and pancreatic juice.
Endpoints are quality of life, gastrointestinal function, and weight development.
Detailed description
Two variations of gastric bypass are compared:
Method 1 (test method):A 200 cm BP-limb (distance Treitz to EA) + 150 cm common channel (EA to ileocecal valve) + Roux-Y-limb variable Method 2 (standard method): A 60 cm BP limb + 150 cm Roux-Y-limb + common channel variable.
Patients are evaluated according to the principles of the Scandinavian Obesity surgery registry (SOReg) with the addition of two additional questionnaires.
FU time is set at 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised study between long and standard biliopancreatic limb in gstric bypass surgery
| Arm | Type | Receives |
|---|---|---|
| standard length bp limb, long alimentary limb | Active comparator | Procedure: gastric bypassour normal way of doing a gastric bypass 60 cm BP limb |
| Long BP limb | Experimental | Procedure: gastric bypass200 cm BP limb |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI 50-65
- Age 18-55
- Conservative attempts at weight reduction failed
Key exclusion criteria (4 listed)
- Inability to speak and understand the Swedish language
- Residence outside the county of Skåne
- Psychotic disease
- Inflammatory bowel disease
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 bypasstwo techniques of gastric bypass for studying the effects of making a long BP-limb | Procedure or surgery | Long BP limb, standard length bp limb, long alimentary limb |
Primary outcome
body weight reduction
Time frame: 5 years
absolute BW reduction, percentage of patients reaching BMI below 30,
1 secondary outcome
gastrointestinal function
Time frame: 5 years
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 25 Feb 2020.
- Derived from this study: PubMed 32931641Nergard BJ, Leifson BG, Gislason H, Hedenbro JL. Effect of different limb lengths on quality of life, eating patterns and gastrointestinal symptoms after Roux-en-Y gastric bypass in superobese patients: randomized study. BJS Open. 2020 Sep 15;4(6):1109-16. doi: 10.1002/bjs5.50334. Online ahead of print.
- Derived from this study: PubMed 26143297Nergard BJ, Lindqvist A, Gislason HG, Groop L, Ekelund M, Wierup N, Hedenbro JL. Mucosal glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide cell numbers in the super-obese human foregut after gastric bypass. Surg Obes Relat Dis. 2015 Nov-Dec;11(6):1237-46. doi: 10.1016/j.soard.2015.03.021. Epub 2015 Apr 2.
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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.
Jan L Hedenbro principal investigator
Lunds Universitets Diabetescentrum
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 bypass in people with Morbid Obesity and Weight Loss, 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 3 inclusion and 4 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 25 Feb 2020. 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?
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?
body weight reduction (time frame: 5 years). 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 NCT01514799, which also lists 2 linked publications.
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 25 Feb 2020.