NCT04712409

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 16, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2022

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

August 17, 2022

Status Verified

August 1, 2022

Enrollment Period

2 years

First QC Date

January 13, 2021

Last Update Submit

August 15, 2022

Conditions

Enteroendocrine Physiological Changes in Superobese Patients Submitted to Two Different Bariatric ProceduresDetermine Whether BPD With DS or SADI-S as Primary or Revisional Surgery is Superior Than the Other as First Choice for the SuperobeseDetermine Whether or Not Revision Surgery is as Effective as Primary Surgery and Understand the Physiological Mechanisms Inherent in These Putative Differences

Keywords

Bariatric SurgerySuperobesityRevisional Bariatric SurgerySingle anastomosis duodeno-ileal bypassBiliopancreatic diversion with duodenal switch

Outcome Measures

Primary Outcomes (7)

  • 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.

    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.

    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).

    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).

    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).

    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).

    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

    From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery

Secondary Outcomes (4)

  • Hypertension remission rates

    From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery

  • Dyslipidemia remission rates

    From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery

  • Sleep Apnea remission rates

    From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery

  • Metabolic syndrome remission rates

    From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery

Other Outcomes (3)

  • Surgical morbidity

    From surgery date to 3 months post-surgery

  • Surgical mortality

    From surgery date to 3 months post-surgery

  • Late morbidity

    From 3 months until 4 years post-surgery

Study Arms (4)

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

Interventions

Single anastomosis duodeno-ileal bypassPROCEDURE

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

Also known as: SADI-S
SADI-S as a primary surgery
Biliopancreatic diversion with duodenal switchPROCEDURE

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.

Also known as: BPD-DS
BPD-DS as a primary surgery
SADI-S as a revisional procedurePROCEDURE

In patients previously submitted to sleeve gastrectomy a single anastomosis duodeno-ileal bypass will be performed as 2nd time surgery

SADI-S as a revisional procedure
BPD-DS as a revisional procedurePROCEDURE

In patients previously submitted to sleeve gastrectomy a biliopancreatic diversion with duodenal switch will be performed as 2nd time surgery

BPD-DS as a revisional procedure

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

São Sebastião Hospital

Santa Maria da Feira, Aveiro District, 4520-211, Portugal

RECRUITING

Hospital de São Sebastião

Santa Maria da Feira, Portugal

RECRUITING

MeSH Terms

Interventions

Biliopancreatic Diversion

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Marta Guimarães, PhD

CONTACT

0034256379700marta.guimaraes@chedv.min-saude.pt

Ana Marta Pereira, MD

CONTACT

0034256379700amarta.pereira@chedv.min-saude.pt

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 13, 2021

First Posted

January 15, 2021

Study Start

August 16, 2020

Primary Completion

August 16, 2022

Study Completion

February 1, 2025

Last Updated

August 17, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

PT(2)