Trials / Completed
CompletedNCT06176443
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 300 (actual)
- Sponsor
- The Society of Bariatric and Metabolic Surgeons of Kazakhstan · Academic / Other
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | One anastomosis gastric bypass with combined fundoplication | FundoRingOAGB |
| PROCEDURE | One anastomosis gastric bypass without combined fundoplication | OAGB |
Timeline
- Start date
- 2020-01-13
- Primary completion
- 2024-01-13
- Completion
- 2024-05-01
- First posted
- 2023-12-19
- Last updated
- 2024-11-21
Locations
1 site across 1 country: Kazakhstan
Source: ClinicalTrials.gov record NCT06176443. Inclusion in this directory is not an endorsement.