Enteroendocrine Physiological Changes in Superobese Patients Submitted to Two Different Bariatric ProceduresSURIDIAB2NCT04712409
Surgical Innovation for Diabetes Treatment 2
A study testing Single anastomosis duodeno-ileal bypass, Biliopancreatic diversion with duodenal switch and SADI-S as a revisional procedure in people with Enteroendocrine Physiological Changes in Superobese Patients Submitted to Two Different Bariatric Procedures and Determine Whether BPD With DS or SADI-S as Primary or Revisional Surgery is Superior Than the Other as First Choice for the Superobese, run by Hospital de Sao Sebastiao at 2 sites in Portugal.
Trial summary
This study aims to understand the enteroendocrine physiological changes in superobese patients submitted to two different bariatric procedures (biliopancreatic diversion with duodenal switch versus single anastomosis duodeno-ileal bypass), when perfomed as primary or revisional surgeries (after a sleeve gastrectomy). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Enteroendocrine Physiological Changes in Superobese Patients Submitted to Two Different Bariatric Procedures, Determine Whether BPD With DS or SADI-S as Primary or Revisional Surgery is Superior Than the Other as First Choice for the Superobese, Determine Whether or Not Revision Surgery is as Effective as Primary Surgery and Understand the Physiological Mechanisms Inherent in These Putative Differences
- What is being tested?
- Single anastomosis duodeno-ileal bypass, Biliopancreatic diversion with duodenal switch and SADI-S as a revisional procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesPortugal
- Study dates
- 16 Aug 2020to 1 Feb 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bariatric surgery candidates
- BMI between 45 and 55 kg/m2
- Aged between 18 and 65 years at surgery
Who cannot join
- Previous abdominal surgery
- Diabetic patients (Hb A1c > 5,7%) prior to the bariatric procedure
- Treatment with antidiabetic drugs, except for purposes other than diabetes treatment, prior to the bariatric procedure
Trial locations and contacts
2 sites in 1 country.
Portugal2 sites, 2 recruiting
- Recruiting
São Sebastião Hospital
Santa Maria da Feira, Aveiro District, 4520-211
Marta Guimarães, PhD, MD, 00351962347298, marta.guimaraes@chedv.min-saude.pt
Ana Marta Pereira, MD, 00351962347298, amarta.pereira@chedv.min-saude.pt
- Recruiting
Hospital de São Sebastião
Santa Maria da Feira
Marta Guimarães, PhD, 0034256379700, marta.guimaraes@chedv.min-saude.pt
Ana Marta Pereira, MD, 0034256379700, amarta.pereira@chedv.min-saude.pt
About this study
Official title: Characterization of Intestinal Hormone and Glucose Dynamics to Unravel the Antidiabetic Effect of Bariatric Surgery
This study aims to understand the enteroendocrine physiological changes in superobese patients submitted to two different bariatric procedures (biliopancreatic diversion with duodenal switch versus single anastomosis duodeno-ileal bypass), when perfomed as primary or revisional surgeries (after a sleeve gastrectomy). The main purpose is to establish the metabolic changes obtained with the sleeve gastrectomy and how the revisional procedure maximizes those changes. Additionally, the study will determine whether BPD with DS or SADI-S is superior than the other as first choice for the superobese.
The study will monitor the enteroendocrine function before and after the ingestion of a mixed meal, in pre-operatory and post-surgery timepoints, comparing both primary and revisional surgeries.
Read the detailed description
Abstract Obesity is a chronic disease whose global incidence keeps rising as the twenty first century goes on. Nowadays, the surgical approach constitutes the best treatment option for these patients, making the sleeve gastrectomy and the gastric bypass the more frequently performed bariatric surgeries.
However, the superobese patients (IMC≥ 50kg/m2) present variable weight loss resistance to the previous techniques, showing better results when submitted to disabsorptive procedures, namely the biliopancreatic diversion with duodenal switch, and the more recently created single anastomosis duodeno-ileal bypass. Each constitutes a revisional surgery option after a primary sleeve gastrectomy, reducing surgical and anesthesia risks. This has brought to light that some superobese patients do not need the revisional procedure as they achieve the weight loss target solely by the vertical gastrectomy.
Supported on the investigators' previous work and extensive experience performing both techniques, they now aim to understand the enteroendocrine physiological changes which each procedure accomplishes and compare them in terms of therapeutic efficacy among the superobese. The utmost goals will be to unravel the advantages of BPD-DS and SADI-S as primary or revisional surgeries, the differences between patients that respond well to sleeve gastrectomy alone and those who do not, and, finally, providing further insights on which procedure should be favoured over the other based on the patient characteristics.
Study Overview:
Participants in this study will have been submitted to either BPD-DS or SADI-S, as a primary or as a revisional surgery.
- Participants visits will be scheduled before surgery and after surgery at 3, 6 , 12 and 24 months for those who receive BPD-DS or SADI-S as a primary procedure.
- Those who are firstly submitted to the sleeve gastrectomy, visits will be scheduled before surgery and after surgery at 3 , 6 and 12 months. The revisional surgery will take place 1 year after the sleeve, with visits scheduled before surgery and after surgery at 3, 6 and 12 months.
In all these visits, detailed participants assessment will include vitals, anthropometric and biochemical evaluation, and the performance of a MMTT with plasma sampling for hormonal profiles. Intraoperative sampling of visceral and subcutaneous adipose tissue will take place during BPD-DS or SADI-S as a primary procedure and during the sleeve gastrectomy and repeated 1 year after the revisional surgery, either BPD-DS or SADI-S, is performed.
Participant Enrolment:
Participants will be selected from the cohort of patients referred for multidisciplinary evaluation by the clinical team for surgical treatment of obesity of the Centro Hospitalar Entre Douro e Vouga (CHEDV). Participants found to be suitable according to the entry criteria and who have accepted to participate will be enrolled in the study and assigned to one of the four study groups according to participants clinical features.
- Conditions
- Enteroendocrine Physiological Changes in Superobese Patients Submitted to Two Different Bariatric Procedures, Determine Whether BPD With DS or SADI-S as Primary or Revisional Surgery is Superior Than the Other as First Choice for the Superobese, Determine Whether or Not Revision Surgery is as Effective as Primary Surgery and Understand the Physiological Mechanisms Inherent in These Putative Differences
- Being tested
- Single anastomosis duodeno-ileal bypass, Biliopancreatic diversion with duodenal switch, SADI-S as a revisional procedure, BPD-DS as a revisional procedure
- Keywords
- Bariatric Surgery, Superobesity, Revisional Bariatric Surgery, Single anastomosis duodeno-ileal bypass, Biliopancreatic diversion with duodenal switch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single anastomosis duodeno-ileal bypassProcedure or surgery
Also called SADI-S
Sleeve gastrectomy followed by division of the duodenum bypassing the jejunum with end-to-side duodeno-ileal diversion
Biliopancreatic diversion with duodenal switchProcedure or surgery
Also called BPD-DS
Sleeve gastrectomy, followed by division of the duodenum bypassing the jejunum with end-to-side duedeno-ileal diversion and Roux-en-y entero-enteric anastomosis, leaving 100 cm common channel.
SADI-S as a revisional procedureProcedure or surgery
In patients previously submitted to sleeve gastrectomy a single anastomosis duodeno-ileal bypass will be performed as 2nd time surgery
BPD-DS as a revisional procedureProcedure or surgery
In patients previously submitted to sleeve gastrectomy a biliopancreatic diversion with duodenal switch will be performed as 2nd time surgery
| Study group | Role | What they receive |
|---|---|---|
| SADI-S as a primary surgery | Active comparator | Not described Receives: Procedure: Single anastomosis duodeno-ileal bypass |
| BPD-DS as a primary surgery | Active comparator | Not described Receives: Procedure: Biliopancreatic diversion with duodenal switch |
| SADI-S as a revisional procedure | Active comparator | Not described Receives: Procedure: SADI-S as a revisional procedure |
| BPD-DS as a revisional procedure | Active comparator | Not described Receives: Procedure: BPD-DS as a revisional procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body mass index
Body mass index (BMI) combines height (in meters) and weight (in kilograms) and is calculated as weight over (height)^2. Therefore, it will be reported in kg/m^2. This parameter will be determined at each study timepoint (pre-operatory, 3, 6 and 12 months post-surgery) at presential visits to the clinic.
Measured: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery
Change in glycated haemoglobin
Glycated haemoglobin (HbA1c) will be measured in percentage (%). This parameter will be assessed at each study timepoint (pre-operatory, 3, 6 and 12 months post- surgery) through routine complete biochemical evaluation.
Measured: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months
Change in glucose dynamic profile
Glucose will be measured in mmol/L. This parameter will be assessed at each study timepoint (pre-operatory, 3, 6 and 12 months post-surgery) under fasting conditions and during a mixed-meal tolerance teste (MMTT) with blood collection at eight timed intervals (-10, 0, 15, 30, 45, 60, 90 and 120 minutes).
Measured: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months
Change in insulin dynamic profile
Insulin will be measured in mIU/L. This parameter will be assessed at each study timepoint (pre-operatory, 3, 6 and 12 months post-surgery) under fasting conditions and during a mixed-meal tolerance teste (MMTT) with blood collection at eight timed intervals (-10, 0, 15, 30, 45, 60, 90 and 120 minutes).
Measured: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery
Change in glucagon dynamic profile
Glucagon will be measured in pmol/L. This parameter will be assessed at each study timepoint (pre-operatory, 3, 6 and 12 months post-surgery) under fasting conditions and during a mixed-meal tolerance teste (MMTT) with blood collection at eight timed intervals (-10, 0, 15, 30, 45, 60, 90 and 120 minutes).
Measured: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery
Change in GLP-1 dynamic profile
Glucagon-like peptide-1 (GLP-1) will be measured in pmol/L. This parameter will be assessed at each study timepoint (pre-operatory, 3, 6 and 12 months post-surgery) under fasting conditions and during a mixed-meal tolerance teste (MMTT) with blood collection at eight timed intervals (-10, 0, 15, 30, 45, 60, 90 and 120 minutes).
Measured: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery
Change in GIP dynamic profile
Glucose-dependent insulinotropic polypeptide (GIP) will be measured in pmol/L. This parameter will be assessed at each study timepoint
Measured: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery
Secondary outcomes (4)
Hypertension remission rates
Measured: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery
Dyslipidemia remission rates
Measured: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery
Sleep Apnea remission rates
Measured: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery
Metabolic syndrome remission rates
Measured: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start16 Aug 2020
- Primary completion16 Aug 2022
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteroendocrine Physiological Changes in Superobese Patients Submitted to Two Different Bariatric ProceduresStudies 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
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Sao Sebastiao
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Ciências Biomédicas Abel Salazar, The Novo Nordisk Foundation Center for Basic Metabolic Research
- Responsible party
- Principal investigator, Marta Guimarães, Hospital de Sao Sebastiao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04712409
- Sponsor's protocol ID
- HSS
- Acronym
- SURIDIAB2
- Status last verified
- Aug 2022
- First submitted
- 13 Jan 2021
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Intestinal Hormone and Glucose Dynamics to Unravel the Antidiabetic Effect of Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04712409
- Acronym / sponsor ID
- SURIDIAB2 / HSS
- Conditions
- Enteroendocrine Physiological Changes in Superobese Patients Submitted to Two Different Bariatric Procedures, Determine Whether BPD With DS or SADI-S as Primary or Revisional Surgery is Superior Than the Other as First Choice for the Superobese, Determine Whether or Not Revision Surgery is as Effective as Primary Surgery and Understand the Physiological Mechanisms Inherent in These Putative Differences
- Keywords
- Bariatric Surgery, Superobesity, Revisional Bariatric Surgery, Single anastomosis duodeno-ileal bypass, Biliopancreatic diversion with duodenal switch
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospital de Sao SebastiaoUniversity, hospital or other
- Collaborators
- Instituto de Ciências Biomédicas Abel Salazar, The Novo Nordisk Foundation Center for Basic Metabolic Research
- Study start
- 16 Aug 2020 (actual)
- Primary completion
- 16 Aug 2022 (actual)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 15 Jan 2021 (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.
This study aims to understand the enteroendocrine physiological changes in superobese patients submitted to two different bariatric procedures (biliopancreatic diversion with duodenal switch versus single anastomosis duodeno-ileal bypass), when perfomed as primary or revisional surgeries (after a sleeve gastrectomy). The main purpose is to establish the metabolic changes obtained with the sleeve gastrectomy and how the revisional procedure maximizes those changes. Additionally, the study will determine whether BPD with DS or SADI-S is superior than the other as first choice for the superobese.
The study will monitor the enteroendocrine function before and after the ingestion of a mixed meal, in pre-operatory and post-surgery timepoints, comparing both primary and revisional surgeries.
Detailed description
Abstract Obesity is a chronic disease whose global incidence keeps rising as the twenty first century goes on. Nowadays, the surgical approach constitutes the best treatment option for these patients, making the sleeve gastrectomy and the gastric bypass the more frequently performed bariatric surgeries.
However, the superobese patients (IMC≥ 50kg/m2) present variable weight loss resistance to the previous techniques, showing better results when submitted to disabsorptive procedures, namely the biliopancreatic diversion with duodenal switch, and the more recently created single anastomosis duodeno-ileal bypass. Each constitutes a revisional surgery option after a primary sleeve gastrectomy, reducing surgical and anesthesia risks. This has brought to light that some superobese patients do not need the revisional procedure as they achieve the weight loss target solely by the vertical gastrectomy.
Supported on the investigators' previous work and extensive experience performing both techniques, they now aim to understand the enteroendocrine physiological changes which each procedure accomplishes and compare them in terms of therapeutic efficacy among the superobese. The utmost goals will be to unravel the advantages of BPD-DS and SADI-S as primary or revisional surgeries, the differences between patients that respond well to sleeve gastrectomy alone and those who do not, and, finally, providing further insights on which procedure should be favoured over the other based on the patient characteristics.
Study Overview:
Participants in this study will have been submitted to either BPD-DS or SADI-S, as a primary or as a revisional surgery.
- Participants visits will be scheduled before surgery and after surgery at 3, 6 , 12 and 24 months for those who receive BPD-DS or SADI-S as a primary procedure.
- Those who are firstly submitted to the sleeve gastrectomy, visits will be scheduled before surgery and after surgery at 3 , 6 and 12 months. The revisional surgery will take place 1 year after the sleeve, with visits scheduled before surgery and after surgery at 3, 6 and 12 months.
In all these visits, detailed participants assessment will include vitals, anthropometric and biochemical evaluation, and the performance of a MMTT with plasma sampling for hormonal profiles. Intraoperative sampling of visceral and subcutaneous adipose tissue will take place during BPD-DS or SADI-S as a primary procedure and during the sleeve gastrectomy and repeated 1 year after the revisional surgery, either BPD-DS or SADI-S, is performed.
Participant Enrolment:
Participants will be selected from the cohort of patients referred for multidisciplinary evaluation by the clinical team for surgical treatment of obesity of the Centro Hospitalar Entre Douro e Vouga (CHEDV). Participants found to be suitable according to the entry criteria and who have accepted to participate will be enrolled in the study and assigned to one of the four study groups according to participants clinical features.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SADI-S as a primary surgery | Active comparator | Procedure: Single anastomosis duodeno-ileal bypass |
| BPD-DS as a primary surgery | Active comparator | Procedure: Biliopancreatic diversion with duodenal switch |
| SADI-S as a revisional procedure | Active comparator | Procedure: SADI-S as a revisional procedure |
| BPD-DS as a revisional procedure | Active comparator | Procedure: BPD-DS as a revisional procedure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Bariatric surgery candidates
- BMI between 45 and 55 kg/m2
- Aged between 18 and 65 years at surgery
Key exclusion criteria (3 listed)
- Previous abdominal surgery
- Diabetic patients (Hb A1c > 5,7%) prior to the bariatric procedure
- Treatment with antidiabetic drugs, except for purposes other than diabetes treatment, prior to the bariatric procedure
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 |
|---|---|---|
| Single anastomosis duodeno-ileal bypassAlso: SADI-SSleeve gastrectomy followed by division of the duodenum bypassing the jejunum with end-to-side duodeno-ileal diversion | Procedure or surgery | SADI-S as a primary surgery |
| Biliopancreatic diversion with duodenal switchAlso: BPD-DSSleeve gastrectomy, followed by division of the duodenum bypassing the jejunum with end-to-side duedeno-ileal diversion and Roux-en-y entero-enteric anastomosis, leaving 100 cm common channel. | Procedure or surgery | BPD-DS as a primary surgery |
| SADI-S as a revisional procedureIn patients previously submitted to sleeve gastrectomy a single anastomosis duodeno-ileal bypass will be performed as 2nd time surgery | Procedure or surgery | SADI-S as a revisional procedure |
| BPD-DS as a revisional procedureIn patients previously submitted to sleeve gastrectomy a biliopancreatic diversion with duodenal switch will be performed as 2nd time surgery | Procedure or surgery | BPD-DS as a revisional procedure |
Primary outcome
Change in body mass index
Time frame: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery
Body mass index (BMI) combines height (in meters) and weight (in kilograms) and is calculated as weight over (height)^2. Therefore, it will be reported in kg/m^2. This parameter will be determined at each study timepoint (pre-operatory, 3, 6 and 12 months post-surgery) at presential visits to the clinic.
Change in glycated haemoglobin
Time frame: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months
Glycated haemoglobin (HbA1c) will be measured in percentage (%). This parameter will be assessed at each study timepoint (pre-operatory, 3, 6 and 12 months post- surgery) through routine complete biochemical evaluation.
Change in glucose dynamic profile
Time frame: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months
Glucose will be measured in mmol/L. This parameter will be assessed at each study timepoint (pre-operatory, 3, 6 and 12 months post-surgery) under fasting conditions and during a mixed-meal tolerance teste (MMTT) with blood collection at eight timed intervals (-10, 0, 15, 30, 45, 60, 90 and 120 minutes).
Change in insulin dynamic profile
Time frame: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery
Insulin will be measured in mIU/L. This parameter will be assessed at each study timepoint (pre-operatory, 3, 6 and 12 months post-surgery) under fasting conditions and during a mixed-meal tolerance teste (MMTT) with blood collection at eight timed intervals (-10, 0, 15, 30, 45, 60, 90 and 120 minutes).
Change in glucagon dynamic profile
Time frame: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery
Glucagon will be measured in pmol/L. This parameter will be assessed at each study timepoint (pre-operatory, 3, 6 and 12 months post-surgery) under fasting conditions and during a mixed-meal tolerance teste (MMTT) with blood collection at eight timed intervals (-10, 0, 15, 30, 45, 60, 90 and 120 minutes).
Change in GLP-1 dynamic profile
Time frame: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery
Glucagon-like peptide-1 (GLP-1) will be measured in pmol/L. This parameter will be assessed at each study timepoint (pre-operatory, 3, 6 and 12 months post-surgery) under fasting conditions and during a mixed-meal tolerance teste (MMTT) with blood collection at eight timed intervals (-10, 0, 15, 30, 45, 60, 90 and 120 minutes).
Change in GIP dynamic profile
Time frame: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery
Glucose-dependent insulinotropic polypeptide (GIP) will be measured in pmol/L. This parameter will be assessed at each study timepoint
4 secondary outcomes
Hypertension remission rates
Time frame: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery
Dyslipidemia remission rates
Time frame: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery
Sleep Apnea remission rates
Time frame: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery
Metabolic syndrome remission rates
Time frame: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Individual participant dataSharing planned: No
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single anastomosis duodeno-ileal bypass, Biliopancreatic diversion with duodenal switch and SADI-S as a revisional procedure in people with Enteroendocrine Physiological Changes in Superobese Patients Submitted to Two Different Bariatric Procedures and Determine Whether BPD With DS or SADI-S as Primary or Revisional Surgery is Superior Than the Other as First Choice for the Superobese, run by Hospital de Sao Sebastiao at 2 sites in Portugal.
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 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 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. 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 Marta Guimarães, PhD (0034256379700 ext. 5575, marta.guimaraes@chedv.min-saude.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body mass index (time frame: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery). The study lists 7 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 17 Aug 2022.