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

NCT ID: NCT06176443

Last Updated: 2024-11-21

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

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-13

Study Completion Date

2024-05-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity, Morbid Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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One anastomosis gastric bypass with combined fundoplication

One anastomosis gastric bypass with combined fundoplication "FundoRing"

Group Type EXPERIMENTAL

One anastomosis gastric bypass with combined fundoplication

Intervention Type PROCEDURE

FundoRingOAGB

One anastomosis gastric bypass without combined fundoplication

One anastomosis gastric bypass without combined fundoplication

Group Type ACTIVE_COMPARATOR

One anastomosis gastric bypass without combined fundoplication

Intervention Type PROCEDURE

OAGB

Interventions

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One anastomosis gastric bypass with combined fundoplication

FundoRingOAGB

Intervention Type PROCEDURE

One anastomosis gastric bypass without combined fundoplication

OAGB

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Society of Bariatric and Metabolic Surgeons of Kazakhstan

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Oral Ospanov, Professor

Role: PRINCIPAL_INVESTIGATOR

Society of Bariatric and Metabolic Surgeons of Kazakhstan" (SBMSK)

Locations

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Oral Ospanov

Astana, Aqmola, Kazakhstan

Site Status

Countries

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Kazakhstan

Other Identifiers

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2_DM_F.R. 2020_2024

Identifier Type: -

Identifier Source: org_study_id

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