Diabetes Remission After RYGBP and RYGBP With Fundus Resection

NCT ID: NCT05854875

Last Updated: 2023-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-22

Study Completion Date

2023-04-10

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Morbid Obesity Bariatric Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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RYGBP

Laparoscopic Roux en Y Gastric Bypass

Group Type ACTIVE_COMPARATOR

Laparoscopic Roux en Y gastric bypass

Intervention Type PROCEDURE

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

RYGBP + FR

Laparoscopic Roux en Y Gastric Bypass with fundus resection

Group Type EXPERIMENTAL

Laparoscopic Roux en Y gastric bypass with fundus resection

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* morbid obesity (ΒΜΙ ≥ 40)
* type II diabetes mellitus (T2DM)
* duration of T2DM shorter than 8 years

Exclusion Criteria

* pregnancy
* type 1 diabetes
* previous gastrointestinal surgeries
* alcohol consumption
* depression
* no compliance
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Patras

OTHER

Sponsor Role lead

Responsible Party

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Dimitrios Kehagias

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Patras, University Hospital of Patras

Pátrai, Rio, Greece

Site Status

Countries

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Greece

Other Identifiers

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5378/35835

Identifier Type: -

Identifier Source: org_study_id

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