Obesity, MorbidBPD-MingroneNCT03111953
Effect of Biliopancreatic Diversion on Glucose Homeostasis
A study testing Roux-en-Y Gastric Bypass Surgery and Biliopancreatic Diversion Surgery in people with Obesity, Morbid, run by Washington University School of Medicine at 1 site in Italy.
Trial summary
Biliopancreatic diversion (BPD) surgery results in greater resolution of type 2 diabetes than all other bariatric surgical procedures, and it is hypothesized that this procedure has specific beneficial effects on glucose homeostasis beyond weight loss alone. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- Roux-en-Y Gastric Bypass Surgery and Biliopancreatic Diversion Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 9 Jan 2014to 28 Jun 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) ≥ 35 kg/m²
- Undergoing either the RYGB or the BPD procedure.
- Able to provide informed consent to participate in the research study
Who cannot join
- Weight > 450 pounds
- Smoke > 7 cigarettes per day
- Previous malabsorptive or restrictive intestinal surgery
- Pregnant or breastfeeding
- Inflammatory intestinal disease
- Diabetes
- Unstable dose of medications in the last 4 weeks before the pre-surgery metabolic studies
- Severe organ dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Biliopancreatic diversion (BPD) surgery results in greater resolution of type 2 diabetes than all other bariatric surgical procedures, and it is hypothesized that this procedure has specific beneficial effects on glucose homeostasis beyond weight loss alone. The BPD procedure is performed in more than 150 patients/year by surgeons at the Division of Obesity and Metabolic Disorders, Catholic University of the Sacred Heart, School of Medicine, in Rome, Italy. The purpose of this study is to provide a better understanding of the effect of the BPD bariatric surgical procedure on insulin action and pancreatic beta cell function. It is hypothesized that weight loss achieved with BPD surgery will have greater effects on insulin sensitivity and beta cell function than weight loss induced by Roux-en-Y gastric bypass (RYGB).
- Conditions
- Obesity, Morbid
- Being tested
- Roux-en-Y Gastric Bypass Surgery, Biliopancreatic Diversion Surgery
- Keywords
- Bariatric Surgery, Roux-en-Y gastric bypass, Biliopancreatic Diversion
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux-en-Y Gastric Bypass SurgeryProcedure or surgery
In Roux-en-Y Gastric Bypass Surgery a small gastric pouch is created and connected to a segment of jejunum. Bowel continuity is restored by reconnecting the "Roux" limb and the biliopancreatic limb approximately ~75-150 cm distal to the gastrojejunostomy. Therefore, ingested food bypasses most of the stomach, the entire duodenum, and a short segment of the jejunum.
Biliopancreatic Diversion SurgeryProcedure or surgery
In Biliopancreatic Diversion Surgery a horizontal gastrectomy is conducted leaving a portion of the stomach, which is connected to the small intestine, ~250 cm from the ileocecal valve and the biliopancreatic limb is connected to the ileum, ~50 cm from the ileocecal valve. Digestive secretions from the biliopancreatic limb mix in the common channel, where ingested food is also delivered by the alimentary limb.
| Study group | Role | What they receive |
|---|---|---|
| RYGB | Active comparator | Subjects received Roux-en-Y Gastric Bypass surgery. Receives: Procedure: Roux-en-Y Gastric Bypass Surgery |
| BPD | Experimental | Subjects received Biliopancreatic Diversion Surgery Receives: Procedure: Biliopancreatic Diversion Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in skeletal muscle insulin sensitivity will be assessed using the Hyperinsulinemic-Euglycemic Clamp (HEC) procedure, before and after weight loss induced by either BPD or RYGB surgery
Insulin sensitivity: The HEC procedure will be used to evaluate insulin sensitivity before and after 20% weight loss induced by either BPD or RYGB surgery
Measured: Change from Baseline up to a possible 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start9 Jan 2014
- Primary completion28 Jun 2016
- Study completion28 Jun 2016
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 Obesity, MorbidStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Catholic University of the Sacred Heart, The Foundation for Barnes-Jewish Hospital
- Responsible party
- Sponsor
- Investigators
- Samuel Klein, MD, Principal investigator, Washington University School of MedicineGeltrude Mingrone, MD, PhD, Principal investigator, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111953
- Sponsor's protocol ID
- 411/14
- Acronym
- BPD-Mingrone
- Status last verified
- Apr 2017
- First submitted
- 13 Mar 2017
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Angelini G, Salinari S, Castagneto-Gissey L, Bertuzzi A, Casella-Mariolo J, Ahlin S, Boskoski I, Gaggini M, Raffaelli M, Costamagna G, Casella G, Marini PL, Gastaldelli A, Bornstein S, Mingrone G. Small intestinal metabolism is central to whole-body insulin resistance. Gut. 2021 Jun;70(6):1098-1109. doi: 10.1136/gutjnl-2020-322073. Epub 2020 Sep 29.
PubMed 32994312Harris LA, Kayser BD, Cefalo C, Marini L, Watrous JD, Ding J, Jain M, McDonald JG, Thompson BM, Fabbrini E, Eagon JC, Patterson BW, Mittendorfer B, Mingrone G, Klein S. Biliopancreatic Diversion Induces Greater Metabolic Improvement Than Roux-en-Y Gastric Bypass. Cell Metab. 2019 Nov 5;30(5):855-864.e3. doi: 10.1016/j.cmet.2019.09.002. Epub 2019 Oct 3.
PubMed 31588013
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Biliopancreatic Diversion on Glucose Homeostasis
- ClinicalTrials.gov ID
- NCT03111953
- Acronym / sponsor ID
- BPD-Mingrone / 411/14
- Conditions
- Obesity, Morbid
- Keywords
- Bariatric Surgery, Roux-en-Y gastric bypass, Biliopancreatic Diversion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Catholic University of the Sacred Heart, The Foundation for Barnes-Jewish Hospital
- Study start
- 9 Jan 2014 (actual)
- Primary completion
- 28 Jun 2016 (actual)
- Study completion
- 28 Jun 2016 (actual)
- First posted
- 13 Apr 2017 (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.
Biliopancreatic diversion (BPD) surgery results in greater resolution of type 2 diabetes than all other bariatric surgical procedures, and it is hypothesized that this procedure has specific beneficial effects on glucose homeostasis beyond weight loss alone. The BPD procedure is performed in more than 150 patients/year by surgeons at the Division of Obesity and Metabolic Disorders, Catholic University of the Sacred Heart, School of Medicine, in Rome, Italy. The purpose of this study is to provide a better understanding of the effect of the BPD bariatric surgical procedure on insulin action and pancreatic beta cell function. It is hypothesized that weight loss achieved with BPD surgery will have greater effects on insulin sensitivity and beta cell function than weight loss induced by Roux-en-Y gastric bypass (RYGB).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RYGB | Active comparator | Procedure: Roux-en-Y Gastric Bypass SurgerySubjects received Roux-en-Y Gastric Bypass surgery. |
| BPD | Experimental | Procedure: Biliopancreatic Diversion SurgerySubjects received Biliopancreatic Diversion Surgery |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body Mass Index (BMI) ≥ 35 kg/m²
- Undergoing either the RYGB or the BPD procedure.
- Able to provide informed consent to participate in the research study
Key exclusion criteria (8 listed)
- Weight > 450 pounds
- Smoke > 7 cigarettes per day
- Previous malabsorptive or restrictive intestinal surgery
- Pregnant or breastfeeding
- Inflammatory intestinal 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 |
|---|---|---|
| Roux-en-Y Gastric Bypass SurgeryIn Roux-en-Y Gastric Bypass Surgery a small gastric pouch is created and connected to a segment of jejunum. Bowel continuity is restored by reconnecting the "Roux" limb and the biliopancreatic limb approximately ~75-150 cm distal to the gastrojejunostomy. Therefore, ingested food bypasses most of the stomach, the entire duodenum, and a short segment of the jejunum. | Procedure or surgery | RYGB |
| Biliopancreatic Diversion SurgeryIn Biliopancreatic Diversion Surgery a horizontal gastrectomy is conducted leaving a portion of the stomach, which is connected to the small intestine, ~250 cm from the ileocecal valve and the biliopancreatic limb is connected to the ileum, ~50 cm from the ileocecal valve. Digestive secretions from the biliopancreatic limb mix in the common channel, where ingested food is also delivered by the alimentary limb. | Procedure or surgery | BPD |
Primary outcome
Change from baseline in skeletal muscle insulin sensitivity will be assessed using the Hyperinsulinemic-Euglycemic Clamp (HEC) procedure, before and after weight loss induced by either BPD or RYGB surgery
Time frame: Change from Baseline up to a possible 9 months
Insulin sensitivity: The HEC procedure will be used to evaluate insulin sensitivity before and after 20% weight loss induced by either BPD or RYGB 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 Apr 2017.
- Derived from this study: PubMed 32994312Angelini G, Salinari S, Castagneto-Gissey L, Bertuzzi A, Casella-Mariolo J, Ahlin S, Boskoski I, Gaggini M, Raffaelli M, Costamagna G, Casella G, Marini PL, Gastaldelli A, Bornstein S, Mingrone G. Small intestinal metabolism is central to whole-body insulin resistance. Gut. 2021 Jun;70(6):1098-1109. doi: 10.1136/gutjnl-2020-322073. Epub 2020 Sep 29.
- Derived from this study: PubMed 31588013Harris LA, Kayser BD, Cefalo C, Marini L, Watrous JD, Ding J, Jain M, McDonald JG, Thompson BM, Fabbrini E, Eagon JC, Patterson BW, Mittendorfer B, Mingrone G, Klein S. Biliopancreatic Diversion Induces Greater Metabolic Improvement Than Roux-en-Y Gastric Bypass. Cell Metab. 2019 Nov 5;30(5):855-864.e3. doi: 10.1016/j.cmet.2019.09.002. Epub 2019 Oct 3.
- Individual participant dataSharing planned: No
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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.
Samuel Klein, MD principal investigator
Washington University School of Medicine
Geltrude Mingrone, MD, PhD principal investigator
Catholic University of the Sacred Heart
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Roux-en-Y Gastric Bypass Surgery and Biliopancreatic Diversion Surgery in people with Obesity, Morbid, run by Washington University School of Medicine at 1 site in Italy.
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 8 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 Apr 2017. 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 Italy. 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?
Change from baseline in skeletal muscle insulin sensitivity will be assessed using the Hyperinsulinemic-Euglycemic Clamp (HEC) procedure, before and after weight loss induced by either BPD or RYGB surgery (time frame: Change from Baseline up to a possible 9 months). 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 NCT03111953, 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 13 Apr 2017.