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
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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COMPLETED
NA
300 participants
INTERVENTIONAL
2020-01-13
2024-05-01
Brief Summary
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Detailed Description
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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 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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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One anastomosis gastric bypass with combined fundoplication
One anastomosis gastric bypass with combined fundoplication "FundoRing"
One anastomosis gastric bypass with combined fundoplication
FundoRingOAGB
One anastomosis gastric bypass without combined fundoplication
One anastomosis gastric bypass without combined fundoplication
One anastomosis gastric bypass without combined fundoplication
OAGB
Interventions
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One anastomosis gastric bypass with combined fundoplication
FundoRingOAGB
One anastomosis gastric bypass without combined fundoplication
OAGB
Eligibility Criteria
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Inclusion Criteria
* Patients with Diabetes Mellitus, Type 2
Exclusion Criteria
* 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
18 Years
60 Years
ALL
No
Sponsors
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The Society of Bariatric and Metabolic Surgeons of Kazakhstan
OTHER
Responsible Party
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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
Countries
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Other Identifiers
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2_DM_F.R. 2020_2024
Identifier Type: -
Identifier Source: org_study_id
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