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Life sciences · Interventional Study
ClinicalTrials.gov · November 6, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT06374368). This is a study registration, not published results. Lead sponsor: University of Ostrava. Recruitment status: TERMINATED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 25 participants (ACTUAL). Conditions: Obesity, Type2 Diabetes. Interventions: PROCEDURE: jejuno-ileal diversion; PROCEDURE: jejuno-colic diversion. Primary outcome measures: Total body weight loss , 36 months; Glycated hemoglobin loss , 36 months; Diabetes medication loss , 36 months; Total cholesterol loss , 36 months; Low density lipoprotein loss , 36 months; High density lipoprotein loss , 36 months; Leptin metabolism evaluation , 36 months; Adiponectin metabolism evaluation , 36 months; Bile acids metabolism evaluation , 36 months. Brief summary: In an effort to replicate metabolic surgery's durable results in metabolic disease while minimizing its risks, two innovative methods has been created. Two surgical methods to create a bowel-to-bowel anastomosis, similar to the type used in current metabolic surgeries. It be to create a jejuno-ileal, side-to-side anastomosis and jejunocolic side-to-side anastomosis. The side-to-side jejuno-ileal anastomosis and side-to-side jejunocolic anastomosis provides two routes for ingested food. The new, shorter route has a malabsorptive effect similar to that seen in Roux en-Y gastric bypass (RYGB) and biliopancreatic diversion (BPD) - procedures which leads to weight loss. Additionally, delivery of non-absorbed macronutrients to the distal ileum, or transverse colon can enhance incretin effect and improve Type 2 Diabetes Mellitus parameters. However, the native route is also preserved, which theoretically reduces the risk of malnutrition, diarrhea, and metabolic derangements seen in other metabolic surgeries.The side-to-side jejuno-ileal anastomosis was already tested in the Pilot Study of the GI Windows Self-Forming Magnetic (SFM) Anastomosis Device for Creation of an Incisionless Small Bowel Bypass for Treatment of Obesity and Diabetes in year 2015 (15). The results of this study demonstrated the safety of this approach without serious adverse events. This non-surgical approach resulted in significant weight loss, favorable changes in insulin and incretin responses to a mixed meal and significant improvement in HbA1c in T2DM (16).In summary, metabolic diseases are a growing pandemic with suboptimal clinical solutions. The surgical side-to-side jejuno-ileal anastomosis and side-to-side jejuno-colic anastomosis without gastrectomy potentially represents a new class of therapy that may produce durable clinical results generally associated with surgery while minimizing its attendant risks.