Diabetes Remission After RYGBP and RYGBP With Fundus Resection

May 2, 2023 updated by: Dimitrios Kehagias, University of Patras

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Rio
      • Patras, Rio, Greece, 26504
        • University of Patras, University Hospital of Patras

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: RYGBP
Laparoscopic Roux en Y Gastric Bypass
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.
Experimental: RYGBP + FR
Laparoscopic Roux en Y Gastric Bypass with fundus resection
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes remission in both groups
Time Frame: At 6 months and 12 months postoperatively
Change in HbA1c levels
At 6 months and 12 months postoperatively
Change in fasting and postprandial glucose levels
Time Frame: At 6 months and 12 months postoperatively
Glucose levels (mg/dl)
At 6 months and 12 months postoperatively
Change in insulin levels, fasting and postprandial
Time Frame: At 6 months and 12 months postoperatively
Insulin levels (μIU/ml)
At 6 months and 12 months postoperatively
Change in HOMA - IR
Time Frame: At 6 months and 12 months postoperatively
HOMA IR calculation with glucose (mg/dl) and insulin (mU/L)
At 6 months and 12 months postoperatively
Change in ghrelin levels
Time Frame: At 6 months and 12 months postoperatively
Fasting and postprandial ghrelin levels (pg/ml)
At 6 months and 12 months postoperatively
Change in GLP-1 levels
Time Frame: At 6 months and 12 months postoperatively
Fasting and postprandial GLP-1 levels (pg/ml)
At 6 months and 12 months postoperatively
Change in PYY levels
Time Frame: At 6 months and 12 months postoperatively
Fasting and postprandial PYY levels (ng/ml)
At 6 months and 12 months postoperatively
Change in glucagon levels
Time Frame: At 6 months and 12 months postoperatively
Fasting and postprandial glucagon levels (pg/ml)
At 6 months and 12 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Patras

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2019

Primary Completion (Actual)

March 2, 2023

Study Completion (Actual)

April 10, 2023

Study Registration Dates

First Submitted

April 21, 2023

First Submitted That Met QC Criteria

May 2, 2023

First Posted (Estimate)

May 11, 2023

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5378/35835

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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