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Completed

NCT Number: NCT06176443

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

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.

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Key information

Conditions

Obesity, Morbid Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oral Ospanov

Astana, Aqmola, 010000, Kazakhstan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

One anastomosis gastric bypass with combined fundoplication

Procedure

FundoRingOAGB

One anastomosis gastric bypass without combined fundoplication

Procedure

OAGB

Primary outcomes

  1. Metabolic improvements of type 2 diabetes

    Time frame: Baseline, at 12, 24, 36 months after surgery

    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

Secondary outcomes

  1. Change of body mass index

    Time frame: Baseline, at 12, 24, 36 months after surgery

    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

Sponsors and collaborators

Lead sponsor

The Society of Bariatric and Metabolic Surgeons of Kazakhstan

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Dec 19, 2023
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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