[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"leakage-anastomotic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:leakage-anastomotic":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"100631003","the-transit-bipartition-with-the-use-of-a-metallic-anastomosis-clip-and-circular-fundocorporeal-gastroplication-100631003",false,"NCT07495020","The Transit Bipartition With the Use of a Metallic Anastomosis 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","MACBIPARTFCG","Inclusion Criteria:\n\n* Clinical diagnosis of Type 2 Diabetes Mellitus\n* BMI 25-35 kg\u002Fm2\n\nExclusion Criteria:\n\n* Insulin dependent diabetes\n* BMI \\\u003C25 and \\>35 kg\u002Fm2\n* History of surgery on the stomach\n* Less than 18 or more than 65 years of age\n* Psychiatric illness\n* Patients unwilling or unable to provide informed consent","ALL","18 Years","65 Years",{"count":21,"type":22},90,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study evaluates a new surgical device - the Metallic Anastomotic Clip (MAC) - for performing a laparoscopic bypass gastroenteroanastomosis with entero-enteric anastomosis (transit bipartition \u002F \"dual-path\" procedure) in patients with type 2 diabetes mellitus (T2DM) who have overweight or Class I obesity (BMI 25-34.9 kg\u002Fm²).\n\nCurrently, most bariatric and metabolic surgery procedures are only approved for patients with a BMI above 35 kg\u002Fm². However, many T2DM patients have BMI less 34.9 kg\u002Fm2 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.\n\nThe 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.\n\nParticipants 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.",[28,29,30,31],"Type 2 Diabetes Mellitus (T2DM)","Obesity & Overweight","Marginal Ulcer (Peptic) or Erosion","Leakage, Anastomotic",[33,34,35,36],"Metallic Anastomotic Clip","Metabolic bariatric surgery","obesity","Type 2 diabetes mellitus","RECRUITING","2026-05-02",{"date":40,"type":41},"2026-05-07","ACTUAL",{"date":43,"type":41},"2026-04-30",{"date":45,"type":22},"2028-05-30",{"name":47,"class":48},"The Society of Bariatric and Metabolic Surgeons of Kazakhstan","OTHER"]