Surgical Innovation for Diabetes Treatment 2

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.

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

Interventions

PROCEDURE

Single anastomosis duodeno-ileal bypass

Sleeve gastrectomy followed by division of the duodenum bypassing the jejunum with end-to-side duodeno-ileal diversion

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.

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

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

Sponsors & Collaborators

• Instituto de Ciências Biomédicas Abel Salazar

  collaborator OTHER

• The Novo Nordisk Foundation Center for Basic Metabolic Research

  collaborator OTHER

• Hospital de Sao Sebastiao

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-16

Primary Completion

2022-08-16

Completion

2025-02-01

Countries

• Portugal

Study Locations