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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06176443
• Other study ID #: 2_DM_F.R. 2020_2024
• Status: Completed
• Phase: N/A
• Start date: January 13, 2020
• Est. completion date: May 1, 2024

Study information

• Verified date: June 2024
• Source: The Society of Bariatric and Metabolic Surgeons of Kazakhstan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 1, 2024
• Est. primary completion date: January 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity, Morbid

Intervention

Procedure:
• One anastomosis gastric bypass with combined fundoplication
FundoRingOAGB
• One anastomosis gastric bypass without combined fundoplication
OAGB

Locations

Country	Name	City	State
Kazakhstan	Oral Ospanov	Astana	Aqmola

Sponsors (1)

Lead Sponsor	Collaborator
The Society of Bariatric and Metabolic Surgeons of Kazakhstan

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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