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

NCT06176443 | Completed

• 1 other identifier: 2_DM_F.R. 2020_2024
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Morbid; Diabetes Mellitus, Type 2

Keywords

Obesity; Metabolic Surgery; FundoRing; One anastomosis gastric bypass; Fundoplication; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change of body mass index

  Baseline, at 12, 24, 36 months after surgery

Study Arms (2)

One anastomosis gastric bypass with combined fundoplication

EXPERIMENTAL

One anastomosis gastric bypass with combined fundoplication "FundoRing"

Procedure: One anastomosis gastric bypass with combined fundoplication

One anastomosis gastric bypass without combined fundoplication

ACTIVE COMPARATOR

One anastomosis gastric bypass without combined fundoplication

Procedure: One anastomosis gastric bypass without combined fundoplication

Interventions

One anastomosis gastric bypass with combined fundoplication PROCEDURE

FundoRingOAGB

One anastomosis gastric bypass with combined fundoplication

One anastomosis gastric bypass without combined fundoplication PROCEDURE

OAGB

One anastomosis gastric bypass without combined fundoplication

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• BMI 25-55 kg/m2
• Patients with Diabetes Mellitus, Type 2

You may not qualify if:

• 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

Sponsors & Collaborators

• The Society of Bariatric and Metabolic Surgeons of Kazakhstan: lead

Study Sites (1)

Oral Ospanov

Astana, Aqmola, 010000, Kazakhstan

Location

MeSH Terms

Conditions

Obesity, Morbid; Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Oral Ospanov, Professor

  Society of Bariatric and Metabolic Surgeons of Kazakhstan" (SBMSK)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2023
• First Posted: December 19, 2023
• Study Start: January 13, 2020
• Primary Completion: January 13, 2024
• Study Completion: May 1, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-11

Locations

KA (1)