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

The Society of Bariatric and Metabolic Surgeons of Kazakhstan

Status: Completed

Conditions: Diabetes Mellitus, Type 2; Obesity, Morbid

Treatments: Procedure: One anastomosis gastric bypass with combined fundoplication; Procedure: One anastomosis gastric bypass without combined fundoplication

Study type: Interventional

Funder types: Other

Identifiers

NCT06176443

2_DM_F.R. 2020_2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

One anastomosis gastric bypass with combined fundoplication

Experimental group

Description:

One anastomosis gastric bypass with combined fundoplication "FundoRing"

Treatment:

Procedure: One anastomosis gastric bypass with combined fundoplication

One anastomosis gastric bypass without combined fundoplication

Active Comparator group

Description:

One anastomosis gastric bypass without combined fundoplication

Treatment:

Procedure: One anastomosis gastric bypass without combined fundoplication