protocolSection identificationModule nctId: NCT06374368, orgStudyIdInfo id: JID-SURG, briefTitle: Small Bowel Diversion, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2019-05-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Ostrava, class: OTHER, collaborators name: Institute for Clinical and Experimental Medicine, collaborators name: Vitkovice Hospital, descriptionModule briefSummary: 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 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 Crea-tion 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 seri-ous 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 A1C in T2DM (16).In summary, metabolic disease is 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., conditionsModule conditions: Obesity, conditions: Type2 Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: jejuno-ileal diversion, interventions name: jejuno-colic diversion, outcomesModule primaryOutcomes measure: Total body weight loss, primaryOutcomes measure: Glycated hemoglobin loss, primaryOutcomes measure: Diabetes medication loss, primaryOutcomes measure: Total cholesterol loss, primaryOutcomes measure: Low density lipoprotein loss, primaryOutcomes measure: High density lipoprotein loss, primaryOutcomes measure: Leptin metabolism evaluation, primaryOutcomes measure: Adiponectin metabolism evaluation, secondaryOutcomes measure: Change from baseline quality of life-Lite, secondaryOutcomes measure: Change from baseline quality of life - Sort Form Survey, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Ostrava, Faculty of Medicine, city: Ostrava, country: Czechia, geoPoint lat: 49.83465, lon: 18.28204, hasResults: False