Previously submitted to: JMIR Research Protocols (no longer under consideration since Jun 05, 2025)
Date Submitted: Jun 25, 2024
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Jejuno-ileal and jejuno-colic diversion as a new bariatric method in the treatment of diabetes and obesity
ABSTRACT
Background:
Obesity is a serious disease that leads significantly to worse global health. Bariatric-metabolic techniques are one of the methods for an effective obesity treatment.
Objective:
Our study should confirm the hypothesis that jejuno-ileal diversion (JID) and jejuno-colic diversion (JCD) lead to weight and fat mass reduction, have a positive effect on endocrine-metabolic function, and increase the bile acid in blood serum. Furthermore, we expect that JKB leads to greater and longer positive changes in body composition and endocrine-metabolic function without a negative effect on patient life.
Methods:
This is a prospective nonrandomised clinical trial. Study subjects who meet Inclusion criteria and baseline procedures undergo surgery: first 20 patients JID / next 20 patients JCD. The subject will have follow-up clinic visits specific to the study at Weeks 1, 2, and 3 and at Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 after the original procedure. At each clinic visit, the subject will undergo a review of medical history, evaluation of adverse events, physical examination (including weight and girth measurements) and blood work (e.g., glycated hemoglobin - HbA1c). At specific intervals, the principal metabolic studies will be performed, including a mixed meal tolerance test. Upper gastrointestinal (GI) series radiographic studies will be performed at baseline and 14 days after the procedure, as well as at the discretion of the principal investigator, focusing on the patency of the anastomosis.
Results:
Statistical analysis will be split into three parts such as continuous outcomes (unpaired t tests); binary outcomes (McNemar’s test or Z tests); baseline demographic and clinical variables (standard approaches / t test versus a null hypothesis/repeated measures analysis of variance.
Conclusions:
The study is consistent with the principles and guidelines of the Declaration of Helsinki and good clinical practice and has been approved by the Ethics Committee. The surgical side-to-side jejuno-ileal anastomosis and side-to-side jejuno-colic anastomosis without gastrectomy potentially represent a new class of therapy with minimising its attendant risks. Clinical Trial: ClinicalTrials.gov NCT06374368.
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