Transit bipartition using a metallic anastomotic clip and circular fundocorporeal gastroplication

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized controlled trial comparing three laparoscopic transit bipartition approaches that use a novel Metallic Anastomotic Clip (MAC) to form gastro‑ileal and entero‑enteric anastomoses. The procedure creates an additional food pathway while preserving normal duodenal digestion to stimulate GLP‑1 secretion and improve glucose metabolism without major malabsorption. One arm includes circular fundocorporeal gastroplication, another pairs the bypass with a sleeve gastrectomy, and a third uses the MAC without gastrectomy. The trial builds on a small pilot of 10 patients that showed technical feasibility and safety of the device.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Clinical diagnosis of Type 2 Diabetes Mellitus
* BMI 25-35 kg/m2

Exclusion Criteria:

* Insulin dependent diabetes
* BMI \<25 and \>35 kg/m2
* History of surgery on the stomach
* Less than 18 or more than 65 years of age
* Psychiatric illness
* Patients unwilling or unable to provide informed consent

Where it's running

• Oral Ospanov
  Astana, Kazakhstan Recruiting

Study contacts

• Principal investigator: Oral Ospanov, Professor — Astana Medical University
• Study coordinator: Oral Ospanov
• Email: bariatric.kz@gmail.com
• Phone: Astana, Kazakhstan, 010000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.