Partial small-bowel diversion for obesity and type 2 diabetes

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

This trial will try two types of partial small-bowel bypass surgery in adults with obesity and type 2 diabetes to help them lose weight and improve blood sugar control.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Ostrava (Academic / other)
• Locations: 2 sites (Ostrava and 1 other locations)
• Trial ID: NCT06374368 on ClinicalTrials.gov

What this trial studies

The trial compares two laparoscopic approaches that create a side-to-side anastomosis to divert a portion of ingested food either from jejunum to ileum or from jejunum to the transverse colon while preserving the native intestinal route. The shorter diversion route is intended to cause partial malabsorption and increase delivery of nutrients to the distal gut to boost incretin responses similar to Roux-en-Y gastric bypass, but with the native pathway kept to potentially reduce malnutrition and diarrhea. Eligible adults (18–65 years, BMI 30–50 kg/m2, with defined glucose/HbA1c criteria) undergo the assigned surgery under general anesthesia and are followed at scheduled visits up to 36 months to monitor weight, glycemic control, and complications. Outcomes include metabolic measures, safety events, and durability of weight and diabetes effects.

Who should consider this trial

Good fit: Adults aged 18–65 with BMI between 30 and 50 kg/m2 who have type 2 diabetes or elevated fasting glucose/HbA1c meeting the trial thresholds are the intended participants.

Not a fit: People with BMI under 30 or over 50, recent (<6 months) diabetes diagnosis, active gastrointestinal, liver or pancreatic disease, uncontrolled psychiatric illness, recent active malignancy, or other major comorbidities are excluded and unlikely to benefit from this procedure in the trial.

Why it matters

Potential benefit: If successful, the procedures could produce durable weight loss and better blood sugar control while reducing the nutritional complications seen with more extensive bypass surgeries.

How similar studies have performed: Established metabolic surgeries like RYGB and BPD produce durable weight loss and diabetes remission, but these specific partial jejuno-ileal and jejuno-colic diversion techniques are relatively novel with limited prior clinical data.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Where this trial is running

Ostrava and 1 other locations

• University of Ostrava — Ostrava, Czechia (Recruiting)
• University of Ostrava, Faculty of Medicine — Ostrava, Czechia (Completed)

Study contacts

• Principal investigator: Marek Bužga, Doc. — University of Ostrava
• Study coordinator: Jana Soldánová

Conditions Obesity; Type2 Diabetes; Type 2 Diabetes; Partial Jejunal Diversion; Partial Jejuno-colic Diversion; Bariatric surgery; Metabolic surgery; Side-to-Side Anastomosis