Small Bowel Diversion
Recruiting · NCT06374368 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Ostrava
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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).
Where it is running
2 locations listed.
- University of Ostrava - Ostrava, Czechia
- University of Ostrava, Faculty of Medicine - Ostrava, Czechia