An interventional study of Laparoscopic transit bipartition with Metallic Anastomotic Clip and Circular Fundocorporeal Gastroplication and Laparoscopic transit bipartition (gastroenteroanastomosis and entero-enteric anastomosis) use the Metallic Anastomotic Clip and with sleeve gastrectomy in Type 2 Diabetes Mellitus (T2DM), Obesity & Overweight and Marginal Ulcer (Peptic) or Erosion, sponsored by The Society of Bariatric and Metabolic Surgeons of Kazakhstan. Recruiting at 1 site in Kazakhstan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by The Society of Bariatric and Metabolic Surgeons of Kazakhstan · Not applicable, Interventional, and Treatment
This study evaluates a new surgical device - the Metallic Anastomotic Clip (MAC) - for performing a laparoscopic bypass gastroenteroanastomosis with entero-enteric anastomosis (transit bipartition / "dual-path" procedure) in patients with type 2 diabetes mellitus (T2DM) who have overweight or Class I obesity (BMI 25-34.9 kg/m²).
Currently, most bariatric and metabolic surgery procedures are only approved for patients with a BMI above 35 kg/m². However, many T2DM patients have BMI less 34.9 kg/m2 and cannot access surgical treatment under existing national guidelines. The transit bipartition procedure addresses this gap by creating a second food pathway from the stomach to the ileum while preserving normal duodenal digestion - producing a strong incretin (GLP-1) effect similar to GLP-1 receptor agonists (e.g., semaglutide), without causing excessive weight loss or requiring lifelong vitamin supplementation.
The MAC is a novel compression anastomotic device designed to replace conventional hand-sewn or stapled anastomoses, potentially reducing complications such as anastomotic leak, bleeding, marginal ulcers, and strictures, while also lowering operative costs.
Participants will be randomised into three groups. The study will assess metabolic outcomes (T2DM remission, glycaemic control), surgical safety, quality of life, and cost-effectiveness over a follow-up period of 2026-2027.
Background:
Type 2 diabetes mellitus (T2DM) is a major global health burden characterised by progressive micro- and macrovascular complications despite pharmacological management. Bariatric and metabolic surgery (BMS) has demonstrated superiority over conservative therapy in achieving durable T2DM remission, primarily through incretin-mediated and weight-independent mechanisms. However, standard BMS indications (BMI ≥35 kg/m²) exclude the majority of T2DM patients who present with overweight or Class I obesity (BMI 25-34.9 kg/m²).
Transit bipartition (the "dual-path" procedure) offers a promising alternative: it preserves the natural duodenal alimentary route while creating an additional gastro-ileal bypass with an entero-enteric anastomosis, thereby stimulating GLP-1 secretion and restoring the incretin effect without the malabsorptive consequences of gastric bypass. This eliminates the need for lifelong micronutrient supplementation.
Device:
The Metallic Anastomotic Clip (MAC) is an authors' proprietary compression anastomotic device developed for laparoscopic creation of bypass gastroenteroanastomosis and entero-enteric anastomosis. The device applies controlled radial compression to achieve tissue approximation and anastomotic healing without sutures or staples. A preliminary pilot study in 10 patients demonstrated technical feasibility and safety.
Study Design:
Prospective, randomised controlled trial (RCT) with three parallel arms:
Group 1: laparoscopic transit bipartition (gastroenteroanastomosis and entero-enteric anastomosis using the Metallic Anastomotic Clip) with circular fundocorporeal gastroplication (without gastrectomy) Group 2: laparoscopic transit bipartition (gastro-ileal anastomosis and entero-enteric anastomosis) using the Metallic Anastomotic Clip with sleeve gastrectomy Group 3: laparoscopic duodenal transit bipartition (single duodenoileal anastomosis) using the Metallic Anastomotic Clip sleeve gastrectomy
Primary Outcomes: HbA1c, fasting glucose, HOMA-IR, remission rate of T2DM (per 2021 ADA/EASD/IFSO consensus criteria) at 12 and 24 months;
Secondary Outcomes:
Anastomotic complication rate (leak, bleeding, stricture, marginal ulcer). BMI, quality of life, operative time, length of hospital stay, morbidity and mortality.
Setting: Surgical Centre of Professor Oral Ospanov, Astana, Kazakhstan. Regulatory: The study will be conducted in accordance with GCP guidelines and the Declaration of Helsinki. The Metallic Anastomotic Clip device will be protected by a utility model patent.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 90 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →The Society of Bariatric and Metabolic Surgeons of Kazakhstan is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group 1: 30 patients with laparoscopic transit bipartition (gastroenteroanastomosis and enteroenterostomy) using the Metallic Anastomotic Clip and with circular fundocorporeal gastroplication without gastrectomy
Procedure: Laparoscopic transit bipartition with Metallic Anastomotic Clip and Circular Fundocorporeal Gastroplication
Group 2: 30 patients with laparoscopic transit bipartition (gastroenteroanastomosis + enteroenterostomy) use Metallic Anastomotic Clip with sleeve gastrectomy
Procedure: Laparoscopic transit bipartition (gastroenteroanastomosis and entero-enteric anastomosis) use the Metallic Anastomotic Clip and with sleeve gastrectomy
Group 3: 30 patients with laparoscopic duodenal transit bipartition use Metallic Anastomotic Clip with circular fundocorporeal gastroplication
Procedure: laparoscopic duodenal transit bipartition using the Metallic Anastomotic Clip with circular fundocorporeal gastroplication without gastrectomy
The procedure begans creation circular fundocorporeal gastroplication without gastrectomy. A gastroplication calibrated over a 36F calibration tube using two layer nonabsorbable suture. The mobilisation of great curvature starts 4 cm above the pylorus and gastroplication starts 7 above the pylorus for the creation 3 cm gastro-ileal compression anastomosis using Metallic Anastomosis Clip (MAC) and leave a distance of 4 cm between the distal corner of the anastomosis and the pylorus. Laparoscopical the cecum and the last ileal loop are identified, and the bowel is retrogradely measured, from the ileocecal valve up to a 300 cm far from it, where the gastro-ileal anastomosis will be made. And than leave a distance of 50 cm from gastroileal anastomosis creation entero-enteric compression anastomosis using the Metallic Anastomotic Clip.
A calibrated sleeve gastrectomy ("gastric sleeve") over a 36F calibration tube and , using stapler loads with staples of variable height. This gastric section starts 7 cm above the pylorus in order to accommodate the 3 cm gastro-ileal compression anastomosis using Metallic Anastomosis Clip (MAC) and leave a distance of 4 cm between the distal corner of the anastomosis and the pylorus. Laparoscopical the cecum and the last ileal loop are identified, and the bowel is retrogradely measured, from the ileocecal valve up to a 300 cm far from it, where the gastro-ileal anastomosis will be made. And than leave a distance of 50 cm from gastroileal compression anastomosis creation entero-enteric compression anastomosis using the Metallic Anastomotic Clip.
The procedure begans creation circular fundocorporeal gastroplication without gastrectomy. A gastroplication calibrated over a 36F calibration tube using two layer nonabsorbable suture. The mobilisation of great curvature and gastroplication starts 4 above the pylorus. The single 3 cm size duodeno-ileal compression anastomosis by use Metallic Anastomosis Clip (MAC) creation post-pyloric at the first duodenal portion (anterior side).
T2DM remission rate
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
Time frame: Baseline, 1, 2, 3 year after surgery
Change of body mass index
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
Time frame: Baseline, 1, 2, 3 year after surgery
Anastomotic complication rate
leak, bleeding, stricture, marginal ulcer
Time frame: <30 day after surgery, 1, 2, 3 year after surgery
Plan to share: No
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The Society of Bariatric and Metabolic Surgeons of Kazakhstan