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Diabetes Remission After RYGBP and RYGBP With Fundus Resection

NCT05854875 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-05-11

No results posted yet for this study

Summary

The goal of this randomized clinical trial is to evaluate glycemic control in patients with morbid obesity and type 2 diabetes after Roux-en-Y gastric bypass (RYGBP) and RYGBP with fundus resection. The main questions to answer are:

* Rate of diabetes remission and the role of the gastrointestinal hormones
* Whether fundus resection leads to improved glycemic control

Patients will randomly undergo typical RYGBP or RYGBP with fundus resection. Gastrointestinal hormones profile \[ghrelin, glucagon-like peptide-1 (GLP-1), peptide YY (PYY), glucagon\], glucose levels and insulin response will be measured preoperatively, at 6 months and at 12 months, during 120-min OGTT.

Conditions

Interventions

PROCEDURE

Laparoscopic Roux en Y gastric bypass

Laparoscopic RYGBP included the creation of a small gastric pouch, with a 200cm biliopancreatic limb and a 150cm alimentary limb.

PROCEDURE

Laparoscopic Roux en Y gastric bypass with fundus resection

Laparoscopic RYGBP included the creation of a small gastric pouch, with a 200cm biliopancreatic limb and a 150cm alimentary limb. Fundus resection is further applied in this arm.

Sponsors & Collaborators

  • University of Patras

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-09-22
Primary Completion
2023-03-02
Completion
2023-04-10

Countries

  • Greece

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 NCT05854875 on ClinicalTrials.gov