Transit bipartition using a metallic anastomotic clip and circular fundocorporeal gastroplication
The Laparoscopic Transit Bipartition Without Gastrectomy With Use of Metallic Anastomosis Clip (MAC) and Circular Fundocorporeal Gastroplication for Treating Type 2 Diabetes Mellitus and Obesity
This trial tries a new metallic anastomotic clip to create a second stomach-to-ileum pathway to help adults with type 2 diabetes and BMI 25–34.9 improve blood sugar control.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | The Society of Bariatric and Metabolic Surgeons of Kazakhstan Academic / other |
| Locations | 1 site (Astana) |
| Trial ID | NCT07495020 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–65 with clinically diagnosed type 2 diabetes and BMI between 25 and 34.9 kg/m² who are not insulin dependent and are willing to undergo laparoscopic surgery are ideal candidates.
Not a fit: People with insulin‑dependent diabetes, prior stomach surgery, BMI outside 25–34.9 kg/m², severe psychiatric illness, or who cannot consent are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the device and procedure could offer durable blood sugar improvement for adults with type 2 diabetes who have overweight or Class I obesity but do not meet current BMI thresholds for bariatric surgery.
How similar studies have performed: Bariatric and metabolic surgical approaches, including transit bipartition concepts, have improved T2DM outcomes in prior work, and a small 10‑patient pilot with the MAC showed technical feasibility though larger randomized data are not yet available.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Astana
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.