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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One anastomosis gastric bypass with combined fundoplication | Experimental | One anastomosis gastric bypass with combined fundoplication "FundoRing" |
|
| One anastomosis gastric bypass without combined fundoplication | Active Comparator | One anastomosis gastric bypass without combined fundoplication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One anastomosis gastric bypass with combined fundoplication | Procedure | FundoRingOAGB |
|
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic improvements of type 2 diabetes | 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 | Baseline, at 12, 24, 36 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change of body mass index | 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 | Baseline, at 12, 24, 36 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oral Ospanov, Professor | Society of Bariatric and Metabolic Surgeons of Kazakhstan" (SBMSK) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oral Ospanov | Astana | Aqmola | 010000 | Kazakhstan |
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| One anastomosis gastric bypass without combined fundoplication | Procedure | OAGB |
|
| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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