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

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Obesity, Morbid, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Procedure: One anastomosis gastric bypass with combined fundoplication
* Procedure: One anastomosis gastric bypass without combined fundoplication


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One anastomosis gastric bypass with combined fundoplication<br>One anastomosis gastric bypass with combined fundoplication FundoRing | Procedure: One anastomosis gastric bypass with combined fundoplication<br>* FundoRingOAGB<br>|
| Active Comparator: One anastomosis gastric bypass without combined fundoplication<br>One anastomosis gastric bypass without combined fundoplication | Procedure: One anastomosis gastric bypass without combined fundoplication<br>* OAGB<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Metabolic Surgery, FundoRing, One anastomosis gastric bypass, Fundoplication, Diabetes Mellitus, Type 2