Overview
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.
Description
- 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.
Eligibility
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