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Diabetes Remission and Hypoabsorptive Bariatric Surgery

NCT06043245 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2023-09-21

No results posted yet for this study

Summary

Bariatric surgery is the most effective treatment to achieve type 2 Diabetes Mellitus (DM) remission in patients with severe obesity. However, there is little evidence of the effectiveness and pathophysiological mechanisms involved in metabolic improvement after hypoabsortive tecniques such as duodenal switch (DS), single anastomosis duodenal switch (SADI-S) or minigastric bypass (MGB). We have designed a randomized study to compare type 2 diabetes remission after the 3 bariatric procedures in patients with severe obesity (BMI \> 45kg/m2) and to study the implication of gastrointestinal hormones, bile acids and gut microbiota in metabolic improvement in each procedure.

Conditions

  • Severe Obesity
  • Diabetes Mellitus, Type 2
  • Bariatric Surgery Candidate

Interventions

PROCEDURE

Duodenal Switch

Classic Duodenal Switch

PROCEDURE

SADI-S

SADI-S with a 300cm common channel

PROCEDURE

Minigastric Bypass

Classic minigastric bypass

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Hospital Universitari de Bellvitge

    lead OTHER

Principal Investigators

  • Nuria Vilarrasa García, PhD, MD · Medical doctor at Hospital Universitari de Bellvitge

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-21
Primary Completion
2026-09-30
Completion
2027-09-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06043245 on ClinicalTrials.gov