NCT06374368Recruiting
Small Bowel Diversion
Jejuno-Ileal and Jejuno-Colic Diversion as a New Bariatric Method in the Treatment of Diabetes and Obesity: Study Protocol for a Prospective Randomised Clinical Trial
Source: ClinicalTrials.gov · Last updated 19 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 2 Dec 2021
- Start date
- 1 May 2019
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- University of Ostrava
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT06374368
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 1 May 2019 to the primary completion date, 31 Dec 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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 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).
Other
- Body Mass Index \>50 or \<30 kg/m2;
- Chronic pancreatitis;
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Recruiting |
| University of Ostrava, Faculty of Medicine Coordinator of this site? Confirm its status | Ostrava | Czechia | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.