Weight LossPhase 3NCT03838276
RYGB AL 150cm BPL 100cm vs RYGB AL 100cc BPL 150cm
A Phase 3 study testing AL 150 BPL100 and AL 100 BPL 150 in people with Weight Loss, run by Hospital General Universitario Elche.
Trial summary
A Roux-en-Y gastric bypass will be performed in all the cases. Patients will be randomized according the limb lengths: Group 1: Alimentary limb (AL) 150cm and biliopancreatic limb (BPL) 100cm Group 2: AL 100cm and BPL 150cm Weight loss will be evaluated 1 year after surgery Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Weight Loss
- What is being tested?
- AL 150 BPL100 and AL 100 BPL 150
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2019to 15 Feb 2020
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI > 40 Kg/m2
- BMI > 35 Kg/m2, associated with obesity-related comorbidities
- Patients undergoing Roux-en-Y gastric bypass as bariatric procedure
Who cannot join
- Patients undergoing Roux-en-Y gastric bypass as revisional procedure
- Patients lost to follow-up
Trial locations and contacts
No sites are listed yet.
Lucas Rivalletto contact
About this study
Official title: Ponderal Outcomes After Roux-en-Y Gastric Bypass With Alimentary Limb (AL) of 150cm and Biliopancreatic Limb (BPL) of 100cm vs AL 100cm and BPL 150cm
A Roux-en-Y gastric bypass will be performed in all the cases. Patients will be randomized according the limb lengths:
- Group 1: Alimentary limb (AL) 150cm and biliopancreatic limb (BPL) 100cm
- Group 2: AL 100cm and BPL 150cm
Weight loss will be evaluated 1 year after surgery
Read the detailed description
A Roux-en-Y gastric bypass will be performed in all the cases. Patients will be randomized according the limb lengths:
- Group 1: Alimentary limb 150cm and biliopancreatic limb 100cm
- Group 2: Alimentary limb 100cm and biliopancreatic limb 150cm
Weight loss will be evaluated 1 year after surgery
- Conditions
- Weight Loss
- Being tested
- AL 150 BPL100, AL 100 BPL 150
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL 150 BPL100Procedure or surgery
Roux-en-Y gastric bypass with 150cm of alimentary limb and 100cm of biliopancreatic limb
AL 100 BPL 150Procedure or surgery
Roux-en-Y gastric bypass with 100cm of alimentary limb and 150cm of biliopancreatic limb
| Study group | Role | What they receive |
|---|---|---|
| AL150 BPL100 | Active comparator | Roux-en-Y gastric bypass with 150cm of alimentary limb and 100cm of biliopancreatic limb Receives: Procedure: AL 150 BPL100 |
| AL100 BPL150 | Experimental | Roux-en-Y gastric bypass with 100cm of alimentary limb and 150cm of biliopancreatic limb Receives: Procedure: AL 100 BPL 150 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Weight loss will be assessed 1 year after surgery
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start15 Feb 2019 (estimated)
- Primary completion15 Feb 2020 (estimated)
- Study completion15 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche
- Investigators
- Santiago de Battista, Study chair, Hospital La PLata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838276
- Sponsor's protocol ID
- HRJC 19-21
- Status last verified
- Feb 2019
- First submitted
- 9 Feb 2019
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ponderal Outcomes After Roux-en-Y Gastric Bypass With Alimentary Limb (AL) of 150cm and Biliopancreatic Limb (BPL) of 100cm vs AL 100cm and BPL 150cm
- ClinicalTrials.gov ID
- NCT03838276
- Acronym / sponsor ID
- HRJC 19-21
- Conditions
- Weight Loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospital General Universitario ElcheUniversity, hospital or other
- Study start
- 15 Feb 2019 (estimated)
- Primary completion
- 15 Feb 2020 (estimated)
- Study completion
- 15 Feb 2020 (estimated)
- First posted
- 12 Feb 2019 (actual)
- 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.
A Roux-en-Y gastric bypass will be performed in all the cases. Patients will be randomized according the limb lengths:
- Group 1: Alimentary limb (AL) 150cm and biliopancreatic limb (BPL) 100cm
- Group 2: AL 100cm and BPL 150cm
Weight loss will be evaluated 1 year after surgery
Detailed description
A Roux-en-Y gastric bypass will be performed in all the cases. Patients will be randomized according the limb lengths:
- Group 1: Alimentary limb 150cm and biliopancreatic limb 100cm
- Group 2: Alimentary limb 100cm and biliopancreatic limb 150cm
Weight loss will be evaluated 1 year after surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AL150 BPL100 | Active comparator | Procedure: AL 150 BPL100Roux-en-Y gastric bypass with 150cm of alimentary limb and 100cm of biliopancreatic limb |
| AL100 BPL150 | Experimental | Procedure: AL 100 BPL 150Roux-en-Y gastric bypass with 100cm of alimentary limb and 150cm of biliopancreatic limb |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI > 40 Kg/m2
- BMI > 35 Kg/m2, associated with obesity-related comorbidities
- Patients undergoing Roux-en-Y gastric bypass as bariatric procedure
Key exclusion criteria (2 listed)
- Patients undergoing Roux-en-Y gastric bypass as revisional procedure
- Patients lost to 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 |
|---|---|---|
| AL 150 BPL100Roux-en-Y gastric bypass with 150cm of alimentary limb and 100cm of biliopancreatic limb | Procedure or surgery | AL150 BPL100 |
| AL 100 BPL 150Roux-en-Y gastric bypass with 100cm of alimentary limb and 150cm of biliopancreatic limb | Procedure or surgery | AL100 BPL150 |
Primary outcome
Weight loss
Time frame: 1 year after surgery
Weight loss will be assessed 1 year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
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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.
Lucas Rivalletto contact
Santiago de Battista study chair
Hospital La PLata
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AL 150 BPL100 and AL 100 BPL 150 in people with Weight Loss, run by Hospital General Universitario Elche.
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 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: status not confirmed, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jaime Ruiz-Tovar (630534808, jruiztovar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: 1 year 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 12 Feb 2019.