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Surgical Innovation for Diabetes Treatment 2 (SURIDIAB2)

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ClinicalTrials.gov Identifier: NCT04712409
Recruitment Status : Recruiting
First Posted : January 15, 2021
Last Update Posted : January 15, 2021
Sponsor:
Collaborators:
Instituto de Ciências Biomédicas Abel Salazar
The Novo Nordisk Foundation Center for Basic Metabolic Research
Information provided by (Responsible Party):
Marta Guimarães, Hospital de Sao Sebastiao

Brief 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). 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.


Condition or disease Intervention/treatment Phase
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 Procedure: Single anastomosis duodeno-ileal bypass Procedure: Biliopancreatic diversion with duodenal switch Procedure: SADI-S as a revisional procedure Procedure: BPD-DS as a revisional procedure Not Applicable

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 and 12 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Characterization of Intestinal Hormone and Glucose Dynamics to Unravel the Antidiabetic Effect of Bariatric Surgery
Estimated Study Start Date : February 1, 2021
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : February 1, 2025

Arm Intervention/treatment
Active Comparator: SADI-S as a primary surgery Procedure: Single anastomosis duodeno-ileal bypass
Sleeve gastrectomy followed by division of the duodenum bypassing the jejunum with end-to-side duodeno-ileal diversion
Other Name: SADI-S

Active Comparator: BPD-DS as a primary surgery Procedure: Biliopancreatic diversion with duodenal switch
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.
Other Name: BPD-DS

Active Comparator: SADI-S as a revisional procedure Procedure: SADI-S as a revisional procedure
In patients previously submitted to sleeve gastrectomy a single anastomosis duodeno-ileal bypass will be performed as 2nd time surgery

Active Comparator: BPD-DS as a revisional procedure Procedure: BPD-DS as a revisional procedure
In patients previously submitted to sleeve gastrectomy a biliopancreatic diversion with duodenal switch will be performed as 2nd time surgery




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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


Secondary Outcome Measures :
  1. Hypertension remission rates [ Time Frame: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery ]
  2. Dyslipidemia remission rates [ Time Frame: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery ]
  3. SAOS remission rates [ Time Frame: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery ]
  4. Metabolic syndrome remission rates [ Time Frame: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery ]

Other Outcome Measures:
  1. Surgical morbidity [ Time Frame: From surgery date to 3 months post-surgery ]
  2. Surgical mortality [ Time Frame: From surgery date to 3 months post-surgery ]
  3. Late morbidity [ Time Frame: From 3 months until 4 years post-surgery ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Bariatric surgery candidates

  • BMI between 45 and 55 kg/m2
  • Aged between 18 and 65 years at surgery

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04712409


Contacts
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Contact: Marta Guimarães, PhD 0034256379700 ext 5575 marta.guimaraes@chedv.min-saude.pt
Contact: Ana Marta Pereira, MD 0034256379700 amarta.pereira@chedv.min-saude.pt

Locations
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Portugal
São Sebastião Hospital Recruiting
Santa Maria Da Feira, Aveiro, Portugal, 4520-211
Contact: Marta Guimarães, PhD, MD    00351962347298    marta.guimaraes@chedv.min-saude.pt   
Contact: Ana Marta Pereira, MD    00351962347298    amarta.pereira@chedv.min-saude.pt   
Principal Investigator: Ana Marta Pereira, MD         
Sub-Investigator: Mário Nora, MD         
Sub-Investigator: Mariana P. Monteiro, PhD, MD         
Hospital de São Sebastião Recruiting
Santa Maria Da Feira, Portugal
Contact: Marta Guimarães, PhD    0034256379700    marta.guimaraes@chedv.min-saude.pt   
Contact: Ana Marta Pereira, MD    0034256379700    amarta.pereira@chedv.min-saude.pt   
Principal Investigator: Ana Marta Pereira, MD         
Sub-Investigator: Mário Nora, MD         
Sub-Investigator: Mariana P. Monteiro, PhD         
Sponsors and Collaborators
Hospital de Sao Sebastiao
Instituto de Ciências Biomédicas Abel Salazar
The Novo Nordisk Foundation Center for Basic Metabolic Research
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Responsible Party: Marta Guimarães, MD, PhD, Hospital de Sao Sebastiao
ClinicalTrials.gov Identifier: NCT04712409    
Other Study ID Numbers: HSS
First Posted: January 15, 2021    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marta Guimarães, Hospital de Sao Sebastiao:
Bariatric Surgery
Superobesity
Revisional Bariatric Surgery
Single anastomosis duodeno-ileal bypass
Biliopancreatic diversion with duodenal switch