NCT06374368

Small Bowel Diversion

Recruiting now NA Last updated 19 August 2025

What this trial tests

NA trial testing jejuno-ileal diversion in Obesity in 80 participants. Currently enrolling.

Timeline

1 May 2019

Primary endpoint
31 December 2028

31 December 2028

Quick facts

Lead sponsor	University of Ostrava
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	80
Start date	1 May 2019
Primary completion	31 December 2028
Estimated completion	31 December 2028
Sites	2 locations across Czechia

Drugs / interventions tested

• jejuno-ileal diversion
• jejuno-colic diversion

Conditions studied

• Obesity — all drugs for Obesity →
• Type2 Diabetes — all drugs for Type2 Diabetes →

Sponsor

University of Ostrava

Who can join

Adults 18 to 65, any sex, with Obesity or Type2 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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
   Buzga M, Holeczy P, Svagera Z, Svoboda P, et al · · 2025 · DOI 10.21203/rs.3.rs-7404898/v1