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NCT06176443 Clinical Trial

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: Active, not recruiting

Administrative data
NCT number NCT06176443
Other study ID # 2_DM_F.R. 2020_2024
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 13, 2020
Est. completion date May 1, 2024

Study information
Verified date March 2024
Source The Society of Bariatric and Metabolic Surgeons of Kazakhstan
Contact n/a
Is FDA regulated No
Health authority
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 Active, not recruiting
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

Study Design

Related Conditions & MeSH terms

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
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