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Small Bowel Diversion

RecruitingNAAges 18 Years - 65 YearsAllUniversity of Ostrava
NCT06374368 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 the

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📋 Eligibility rules (as published)
Inclusion Criteria: * age 18-65 years at screening; * Body mass index ≥30 or ≤50kg/m2; * If subject has Type 2 Diabetes: fasting plasma glucose greater than 6,1 mmol/l at time of enrollment if not treated with anti-diabetic medication; * If on no diabetes medications, Hemoglobin A1C between and including 6.5 and 9.0 at time of enrollment. Exclusion Criteria: * Body Mass Index \>50 or \<30 kg/m2; * Diagnosis of Type 2 diabetes less than 6 months; * History of suspected gastrointestinal disease (for example cirrhosis, inflammatory bowel disease); * History of active malignancy (not in remission) with the exception of squamous or basal cell carcinoma of the skin; * Ongoing systemic infection; * Chronic pancreatitis; * Chronic liver disease of any cause; * Poorly controlled psychiatric disease (for example ongoing major depression, schizophrenia, borderline personality, suicidality, psychosis); * Any history of an eating disorder within the past 5 years; * Pre-existing severe comorbid cardio-respiratory disease (for example congestive heart failure, cardiac arrhythmia, coronary artery disease, chronic obstructive lung disease, pulmonary embolism); * uncontrolled hypertension (systolic Blood Preassure \> 150 mm Hg or diastolic Blood Preassure \> 100 mm Hg).
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What it tests

  • jejuno-ileal diversion
  • jejuno-colic diversion
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Where

2 sites
University of Ostrava
Ostrava, Czechia
University of Ostrava, Faculty of Medicine
Ostrava, Czechia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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