Impact of an Increased Restrictive Factor of One Anastomosis Gastric Bypass on Metabolic Outcomes Type 2 Diabetes.

March 24, 2024 updated by: The Society of Bariatric and Metabolic Surgeons of Kazakhstan

Impact of an Increased Restrictive Factor of One Anastomosis Gastric Bypass Using a "FundoRing" Fundoplication on Metabolic Outcomes in Type 2 Diabetes Mellitus: a Randomized Controlled Trial

The purpose of the study is to evaluate the effect of an increased restrictive factor of one gastric anastomosis (OAGB) using a "FundoRing" fundoplication on metabolic outcomes in type 2 diabetes mellitus. The randomized controlled trial compared two interventional procedures: one group - using the original fundoplication procedure to enhance the restrictive effect and another group without fundoplication in the standard version of the OAGB.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The randomized controlled trial compared two interventional procedures: one group - using the original fundoplication procedure to enhance the restrictive effect and another group without fundoplication in the standard version of the OAGB.

The purpose of the study is to evaluate the effect of an increased restrictive factor of one gastric anastomosis (OAGB) using a "FundoRing" fundoplication on metabolic outcomes in type 2 diabetes mellitus.

The main hypothesis is that an increase in the restrictive effect will lead to an increase in the metabolic effect and an increase in its persistence over time.

Study Type

Interventional

Enrollment (Actual)

200

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

  • Kazakhstan
    • Aqmola
      • Astana, Aqmola, Kazakhstan, 010000
        • Oral Ospanov

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:

  • BMI 25-55 kg/m2
  • Patients with Diabetes Mellitus, Type 2

Exclusion Criteria:

  • BMI <25 and >55 kg/m2
  • Patients without Diabetes Mellitus, Type 2
  • History of surgery on the stomach
  • Less than 18 or more than 60 years of age
  • Psychiatric illness
  • Patients unwilling or unable to provide informed consent

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: One anastomosis gastric bypass with combined fundoplication
One anastomosis gastric bypass with combined fundoplication "FundoRing"
Procedure: One anastomosis gastric bypass with combined fundoplication
FundoRingOAGB
Active Comparator: One anastomosis gastric bypass without combined fundoplication
Procedure: One anastomosis gastric bypass without combined fundoplication
OAGB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic improvements of type 2 diabetes
Time Frame: Baseline, at 12, 24, 36 months after surgery
Change % of Glycosylated Hemoglobin. A1C level is below 5.7% - full remisson, a level of 5.7% to 6.4% indicates partial remission , and a level of 6.5% or more indicates diabetes
Baseline, at 12, 24, 36 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of body mass index
Time Frame: Baseline, at 12, 24, 36 months after surgery
The measure is assessing a change of body mass index. Weight (kg) and height (cm) will be combined with the report of measurement by body mass index (BMI) kg/m2
Baseline, at 12, 24, 36 months after surgery

Collaborators and Investigators

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

Sponsor

The Society of Bariatric and Metabolic Surgeons of Kazakhstan

Investigators

  • Principal Investigator: Oral Ospanov, Professor, Society of Bariatric and Metabolic Surgeons of Kazakhstan" (SBMSK)

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)

January 13, 2020

Primary Completion (Actual)

January 13, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

December 9, 2023

First Submitted That Met QC Criteria

December 9, 2023

First Posted (Actual)

December 19, 2023

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 24, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2_DM_F.R. 2020_2024

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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