Back to results

Diabetes Remission After RYGBP and RYGBP With Fundus Resection

Primary Purpose

Type 2 Diabetes, Morbid Obesity, Bariatric Surgery

Status

Completed

Phase

Not Applicable

Locations

Greece

Study Type

Interventional

Intervention

Laparoscopic Roux en Y gastric bypass

Laparoscopic Roux en Y gastric bypass with fundus resection

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Gastric Fundus, Gastrointestinal Hormones

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Patras, University Hospital of Patras

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

RYGBP

RYGBP + FR

Arm Description

Laparoscopic Roux en Y Gastric Bypass

Laparoscopic Roux en Y Gastric Bypass with fundus resection

Outcomes

Primary Outcome Measures

Diabetes remission in both groups

Change in HbA1c levels

Change in fasting and postprandial glucose levels

Glucose levels (mg/dl)

Change in insulin levels, fasting and postprandial

Insulin levels (μIU/ml)

Change in HOMA - IR

HOMA IR calculation with glucose (mg/dl) and insulin (mU/L)

Change in ghrelin levels

Fasting and postprandial ghrelin levels (pg/ml)

Change in GLP-1 levels

Fasting and postprandial GLP-1 levels (pg/ml)

Change in PYY levels

Fasting and postprandial PYY levels (ng/ml)

Change in glucagon levels

Fasting and postprandial glucagon levels (pg/ml)

Secondary Outcome Measures

Full Information

NCT ID

NCT05854875

First Posted

April 21, 2023

Last Updated

May 2, 2023

Sponsor

University of Patras

1. Study Identification

Unique Protocol Identification Number

NCT05854875

Brief Title

Diabetes Remission After RYGBP and RYGBP With Fundus Resection

Official Title

RYGBP vs RYGBP With Fundus Resection for Morbid Obese Patients With Type 2 Diabetes. Evaluation of the Gastric Fundus in Glycemic Control. A Randomized Clinical Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

September 22, 2019 (Actual)

Primary Completion Date

March 2, 2023 (Actual)

Study Completion Date

April 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Patras

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes, Morbid Obesity, Bariatric Surgery

Keywords

Gastric Fundus, Gastrointestinal Hormones

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RYGBP

Arm Type

Active Comparator

Arm Description

Laparoscopic Roux en Y Gastric Bypass

Arm Title

RYGBP + FR

Arm Type

Experimental

Arm Description

Laparoscopic Roux en Y Gastric Bypass with fundus resection

Intervention Type

Procedure

Intervention Name(s)

Laparoscopic Roux en Y gastric bypass

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Laparoscopic Roux en Y gastric bypass with fundus resection

Intervention Description

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.

Primary Outcome Measure Information:

Title

Diabetes remission in both groups

Description

Change in HbA1c levels

Time Frame