CompletedNot Applicable

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

Kazakhstan300 participantsStarted 2020-01-13

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Metabolic improvements of type 2 diabetes

Timeframe: Baseline, at 12, 24, 36 months after surgery

Trial details

NCT IDNCT06176443

SponsorThe Society of Bariatric and Metabolic Surgeons of Kazakhstan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-13

View on ClinicalTrials.gov More Obesity, Morbid trials