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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06176443

Enrollment

300

Registered

2023-12-19

Start date

2020-01-13

Completion date

2024-05-01

Last updated

2024-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2, Obesity, Morbid

Keywords

Obesity, Metabolic Surgery, FundoRing, One anastomosis gastric bypass, Fundoplication, Diabetes Mellitus, Type 2

Brief summary

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

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.

Interventions

PROCEDUREOne anastomosis gastric bypass with combined fundoplication

FundoRingOAGB

PROCEDUREOne anastomosis gastric bypass without combined fundoplication

OAGB

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Metabolic improvements of type 2 diabetes	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

Secondary

Measure	Time frame	Description
Change of body mass index	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

Countries

Kazakhstan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026