Biliopancreatic Diversion With Duodenal SwitchNCT02069223
Physiological Impact of Each Component of the Biliopancreatic Diversion With Duodenal Switch and Sleeve Gastrectomy
A study testing Gastrectomy and BPD-DS in people with Biliopancreatic Diversion With Duodenal Switch and Gastrectomy, run by Laval University at 1 site in Canada.
Trial summary
Bariatric surgery procedures promote weight loss by limiting the amount of food consumed through reduction of the size of the stomach and by decreasing absorption of nutrients through reorganizing or bypassing portions of the small intestine. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Biliopancreatic Diversion With Duodenal Switch, Gastrectomy
- What is being tested?
- Gastrectomy and BPD-DS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2014to Dec 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and Women between 18-60 years old;
- BMI ≥ 45 à ≤ 55 kg/m2;
- Subjects capable of understanding and being able to sign a consent form;
- Subjects capable of following the protocol directives, including the proposed visits (timeline);
- Subjects living within a reasonable distance from the hospital and capable of being present at all required visits.
Who cannot join
- Pregnant women or women who plan on becoming pregnant during the study, or women in fertile age range who refuse proper contraceptive methods during the study. (Must have negative pregnancy test at the moment of enrollment and use medically acceptable contraception which include: oral contraceptives, injectable or implantable contraceptives, intrauterine devices or double-barrier method ie. condoms and diaphragm);
- Diabetics
- Subjects with HbA1c ≥ 6,5 % or fasting Glucose ≥7mmol/l or non-fasting Glucose ≥11mmol/l;
- Previous oesophagal, gastric or bariatric surgery;
- Irritable bowel syndrome, unexplained intermittent vomiting, severe abdominal pain, diarrhea or chronic constipation;
- History of duodenal or gastric ulcers;
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- Pre-operative hypoalbuminuria (<35g/l);
- History of renal disease, hepatic disease (cirrhosis) or severe cardiac or pulmonary disease;
- Corticosteroid intake in the previous month;
- Presence of psychiatric problems or behavioral issues that could limit subject's capacity at understanding the procedure and to conform to medical/surgical recommendations;
- History of drug use or alcoholism in previous 12 months before study;
- History of inflammatory diseases of the gastro-intestinal tract (Esophagitis, varices, gastric or duodenal ulcers, Crohn's disease, congenital or acquired anomalies of the digestive tract).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
CRIUCPQ
Québec, Quebec, G1V4G5
Marc Lapointe, 4186568711 ext. 2136, marc.lapointe@criucpq.ulaval.ca
André Tchernof
About this study
Bariatric surgery procedures promote weight loss by limiting the amount of food consumed through reduction of the size of the stomach and by decreasing absorption of nutrients through reorganizing or bypassing portions of the small intestine. Among the procedures used to induce weight loss, sleeve gastrectomy (SG) was initially developed in the early 90's as the restrictive component of a biliopancreatic diversion with duodenal switch (BPD-DS). It was then offered by laparoscopy as a staged-approach in order to reduce peri-operative complications in high-risk patients. The second step of the surgery (i.e. the duodenal switch) was planned when sufficient weight loss had been obtained. However, it was observed that some patients experienced appreciable weight loss with the SG alone, and did not require a second-stage surgery, thus avoiding the side-effects of a malabsorptive surgery. This led to the surge in popularity of SG as a stand-alone operation, because of its relative technical simplicity, feasibility, and good outcomes. Multiple mechanisms have been postulated to induce metabolic recovery and weight loss following surgery. The independent effects of each component of the BPD-DS with SG have never been investigated in humans within a well-controlled study design. The general objective of the present project is to assess the impact of each component of the BPD-DS and SG, either combined of separated, on physiological variables potentially responsible for metabolic recovery. Patients will be randomized to undergo one of three surgical sequences: 1) SG followed by BPD-DS one year later; 2) BPD-DS followed by SG one year later; or 3) SG and BPD-DS within a single operation. A series of tests will be performed at baseline, at 1 year, and 2 years after the initial surgery. We propose two Specific Aims to asses 1) the impact of each surgical component on the hormonal determinants of metabolic recovery; and 2) the impact of weight loss responses on subcutaneous and visceral adipose tissue function improvements. This project will help better understand the mechanisms underlying metabolic recovery following weight loss surgery.
- Being tested
- Gastrectomy, BPD-DS
- Keywords
- Biliopancreatic Diversion with Duodenal Switch, Gastrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GastrectomyProcedure or surgery
BPD-DSProcedure or surgery
Also called Biliopancreatic Diversion with Duodenal Switch
| Study group | Role | What they receive |
|---|---|---|
| Gastrectomy | Active comparator | Subjects in this group will undergo a gastrectomy as their first surgery with a BPD-DS 1-year later. Receives: Procedure: Gastrectomy; Procedure: BPD-DS |
| BPD-DS | Active comparator | Subjects in this group will undergo a BPD-DS as their first surgery with a gastrectomy 1-year later. Receives: Procedure: Gastrectomy; Procedure: BPD-DS |
| Gastrectomy+BPD-DS | Active comparator | Subjects in this group will undergo a gastrectomy AND a BPD-DS concomitantly. They will then be closely monitored for the remainder of the study. Receives: Procedure: Gastrectomy; Procedure: BPD-DS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the changes in Satiety Levels and the changes in Incretin Levels
- Satiety determination via questionnaires
- Incretin levels
Measured: Baseline, 12, 24 months
Measure the changes of adipose tissue cells sizes and macrophage infiltration
- Adipose Tissue cell sizing
- Adipose Tissue macrophage infiltration via histology
Measured: Baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliopancreatic Diversion With Duodenal SwitchStudies of the same condition, open and under way.
- More trials run by Laval 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069223
- Sponsor's protocol ID
- 21003
- Status last verified
- May 2014
- First submitted
- 6 Feb 2014
- Last updated
- 16 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Impact of Each Component of the Biliopancreatic Diversion With Duodenal Switch and Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT02069223
- Acronym / sponsor ID
- 21003
- Keywords
- Biliopancreatic Diversion with Duodenal Switch, Gastrectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Johnson & Johnson, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
- Study start
- Jan 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 24 Feb 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.
Bariatric surgery procedures promote weight loss by limiting the amount of food consumed through reduction of the size of the stomach and by decreasing absorption of nutrients through reorganizing or bypassing portions of the small intestine. Among the procedures used to induce weight loss, sleeve gastrectomy (SG) was initially developed in the early 90's as the restrictive component of a biliopancreatic diversion with duodenal switch (BPD-DS). It was then offered by laparoscopy as a staged-approach in order to reduce peri-operative complications in high-risk patients. The second step of the surgery (i.e. the duodenal switch) was planned when sufficient weight loss had been obtained. However, it was observed that some patients experienced appreciable weight loss with the SG alone, and did not require a second-stage surgery, thus avoiding the side-effects of a malabsorptive surgery. This led to the surge in popularity of SG as a stand-alone operation, because of its relative technical simplicity, feasibility, and good outcomes. Multiple mechanisms have been postulated to induce metabolic recovery and weight loss following surgery. The independent effects of each component of the BPD-DS with SG have never been investigated in humans within a well-controlled study design. The general objective of the present project is to assess the impact of each component of the BPD-DS and SG, either combined of separated, on physiological variables potentially responsible for metabolic recovery. Patients will be randomized to undergo one of three surgical sequences: 1) SG followed by BPD-DS one year later; 2) BPD-DS followed by SG one year later; or 3) SG and BPD-DS within a single operation. A series of tests will be performed at baseline, at 1 year, and 2 years after the initial surgery. We propose two Specific Aims to asses 1) the impact of each surgical component on the hormonal determinants of metabolic recovery; and 2) the impact of weight loss responses on subcutaneous and visceral adipose tissue function improvements. This project will help better understand the mechanisms underlying metabolic recovery following weight loss surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gastrectomy | Active comparator | Procedure: Gastrectomy, Procedure: BPD-DSSubjects in this group will undergo a gastrectomy as their first surgery with a BPD-DS 1-year later. |
| BPD-DS | Active comparator | Procedure: Gastrectomy, Procedure: BPD-DSSubjects in this group will undergo a BPD-DS as their first surgery with a gastrectomy 1-year later. |
| Gastrectomy+BPD-DS | Active comparator | Procedure: Gastrectomy, Procedure: BPD-DSSubjects in this group will undergo a gastrectomy AND a BPD-DS concomitantly. They will then be closely monitored for the remainder of the study. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men and Women between 18-60 years old;
- BMI ≥ 45 à ≤ 55 kg/m2;
- Subjects capable of understanding and being able to sign a consent form;
- Subjects capable of following the protocol directives, including the proposed visits (timeline);
- Subjects living within a reasonable distance from the hospital and capable of being present at all required visits.
Key exclusion criteria (12 listed)
- Pregnant women or women who plan on becoming pregnant during the study, or women in fertile age range who refuse proper contraceptive methods during the study. (Must have negative pregnancy test at the moment of enrollment and use medically acceptable contraception which include: oral contraceptives, injectable or implantable contraceptives, intrauterine devices or double-barrier method ie. condoms and diaphragm);
- Diabetics
- Subjects with HbA1c ≥ 6,5 % or fasting Glucose ≥7mmol/l or non-fasting Glucose ≥11mmol/l;
- Previous oesophagal, gastric or bariatric surgery;
- Irritable bowel syndrome, unexplained intermittent vomiting, severe abdominal pain, diarrhea or chronic constipation;
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 |
|---|---|---|
| Gastrectomy | Procedure or surgery | BPD-DS, Gastrectomy, Gastrectomy+BPD-DS |
| BPD-DSAlso: Biliopancreatic Diversion with Duodenal Switch | Procedure or surgery | BPD-DS, Gastrectomy, Gastrectomy+BPD-DS |
Primary outcome
Measure the changes in Satiety Levels and the changes in Incretin Levels
Time frame: Baseline, 12, 24 months
* Satiety determination via questionnaires * Incretin levels
Measure the changes of adipose tissue cells sizes and macrophage infiltration
Time frame: Baseline, 12 months
* Adipose Tissue cell sizing * Adipose Tissue macrophage infiltration via histology
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2014.
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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 Gastrectomy and BPD-DS in people with Biliopancreatic Diversion With Duodenal Switch and Gastrectomy, run by Laval University at 1 site in Canada.
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 5 inclusion and 12 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 16 May 2014. 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 Canada. 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 Marc Lapointe (4186568711 ext. 2136, marc.lapointe@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the changes in Satiety Levels and the changes in Incretin Levels (time frame: Baseline, 12, 24 months). The study lists 2 primary outcomes in all. 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 16 May 2014.