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

Status: Recruiting
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Contact Information
Primary
Jana Soldánová
jana.soldanova@osu.cz
+420553462823
Time Frame
Start Date: 2019-05-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 80
Treatments
Active_comparator: obese patients with jejuno-ileal diversion
Jejuno-ileal diversion without gastric restriction using standard bariatric surgical technique with standard staplers and surgical suturing.
Active_comparator: obese patients with jejuno-colic diversion
Jejuno-colic diversion without gastric restriction using standard bariatric surgical technique with standard staplers and surgical suturing
Sponsors
Collaborators: Vitkovice Hospital, Institute for Clinical and Experimental Medicine
Leads: University of Ostrava

This content was sourced from clinicaltrials.gov