Small Bowel Diversion

NCT06374368 | Recruiting

• 1 other identifier: JID-SURG
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Obesity; Type2 Diabetes

Keywords

Obesity; Type 2 Diabetes; Partial Jejunal Diversion; Partial Jejuno-colic Diversion; Bariatric surgery; Metabolic surgery; Side-to-Side Anastomosis

Outcome Measures

Primary Outcomes (9)

• Total body weight loss

  Weight change in percentage

  36 months

• Glycated hemoglobin loss

  Glycated hemoglobin change in blood

  36 months

• Diabetes medication loss

  Reduction in diabetes medication requirements (for diabetic cohort) - absolute value

  36 months

• Total cholesterol loss

  Total cholesterol loss in blood

  36 months

• Low density lipoprotein loss

  Low density lipoprotein loss in blood

  36 months

• High density lipoprotein loss

  High density lipoprotein loss in blood

  36 months

• Leptin metabolism evaluation

  Leptin value increase/decrease in blood

  36 months

• Adiponectin metabolism evaluation

  Adiponectin value increase/decrease in blood

  36 months

• Bile acids metabolism evaluation

  Bile acids value increase/decrease in blood

  36 months

Secondary Outcomes (2)

• Change from baseline quality of life-Lite

  36 months

• Change from baseline quality of life - Sort Form Survey

  36 months

Study Arms (2)

obese patients with jejuno-ileal diversion

ACTIVE COMPARATOR

Jejuno-ileal diversion without gastric restriction using standard bariatric surgical technique with standard staplers and surgical suturing.

Procedure: jejuno-ileal diversion

obese patients with jejuno-colic diversion

ACTIVE COMPARATOR

Jejuno-colic diversion without gastric restriction using standard bariatric surgical technique with standard staplers and surgical suturing

Procedure: jejuno-colic diversion

Interventions

jejuno-ileal diversion PROCEDURE

The surgery is performed in general anesthesia with orotracheal intubation. The laparoscopic approach is used. After establishing pneumoperitoneum (insufluation of the abdominal cavity with CO2) the 1th. trocar and laparoscopic camera are introduced through small incision. After visual control of abdominal cavity additional 2-3 trocars for operating instruments are introduced. The site of future anastomosis is identified (45 cm from ligament of Treitz on jejunum and 45 cm for the ileocoecal junction on ileum). The anastomosis between these two parts of jejunum and ileum is created by the means of linear stapler (45 mm).

obese patients with jejuno-ileal diversion

jejuno-colic diversion PROCEDURE

The surgery is performed in general anesthesia with orotracheal intubation. The laparoscopic approach is used. After establishing pneumoperitoneum (insufluation of the abdominal cavity with CO2) the 1th. trocar and laparoscopic camera are introduced through small incision. After visual control of abdominal cavity additional 2-3 trocars for operating instruments are introduced. The anastomosis is created between jejunum (45 from ligament of Treitz) and transverse colon (behind the liver flexure).

obese patients with jejuno-colic diversion

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Ostrava: lead
• Institute for Clinical and Experimental Medicine: collaborator
• Vitkovice Hospital: collaborator

Study Sites (2)

University of Ostrava

Ostrava, 70300, Czechia

RECRUITING

University of Ostrava, Faculty of Medicine

Ostrava, Czechia

COMPLETED

Related Publications (21)

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MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Marek Bužga, Doc.

  University of Ostrava

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jana Soldánová

CONTACT

+420553462823; jana.soldanova@osu.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: April 18, 2024
• Study Start: May 1, 2019
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (2)