Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06374368

Jejuno-Ileal and Jejuno-Colic Diversion as New Bariatric Methods for Treating Diabetes and Obesity: Protocol for a Randomized Clinical Trial

Led by University of Ostrava · Updated on 2025-08-19

80

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Ostrava

Lead Sponsor

I

Institute for Clinical and Experimental Medicine

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating two new surgical methods called jejuno-ileal diversion and jejuno-colic diversion to treat obesity and Type 2 Diabetes. These procedures create a bowel-to-bowel connection allowing food to pass through two routes, aiming to mimic the effects of metabolic surgeries like gastric bypass but with fewer risks such as malnutrition or diarrhea. The study is a prospective randomized clinical trial sponsored by the University of Ostrava to assess the safety and effectiveness of these innovative approaches. The surgeries are performed under general anesthesia using a laparoscopic technique. For jejuno-ileal diversion, an anastomosis is created between the jejunum and ileum using a linear stapler, and for jejuno-colic diversion, the connection is made between the jejunum and transverse colon. After surgery, patients will have follow-up visits scheduled frequently during the first weeks and then up to 36 months to monitor health and surgical outcomes. Participants will attend clinic visits at specific intervals to assess medical history, physical health including weight and body measurements, blood work such as glycated hemoglobin levels, and metabolic studies like mixed meal tolerance tests. Imaging studies will also be done before and after surgery to check the surgical connections. The primary outcomes include weight loss and improvements in diabetes-related markers over 36 months, with safety and quality of life also monitored through questionnaires and clinical exams.

CONDITIONS

Brief Title

Small Bowel Diversion

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 65 years at screening
  • Body mass index (BMI) between 30 and 50 kg/m2
  • If diagnosed with Type 2 Diabetes, fasting plasma glucose greater than 6.1 mmol/l if not on anti-diabetic medication
  • If not on diabetes medications, Hemoglobin A1C between 6.5 and 9.0 at enrollment
Not Eligible

You will not qualify if you...

  • Body mass index (BMI) less than 30 or greater than 50 kg/m2
  • Diagnosis of Type 2 Diabetes less than 6 months ago
  • History of suspected gastrointestinal disease such as cirrhosis or inflammatory bowel disease
  • History of active cancer not in remission, except skin squamous or basal cell carcinoma
  • Ongoing systemic infection
  • Chronic pancreatitis
  • Chronic liver disease from any cause
  • Poorly controlled psychiatric illness including major depression, schizophrenia, or psychosis
  • History of eating disorder within the past 5 years
  • Severe heart or lung disease such as congestive heart failure or coronary artery disease
  • Uncontrolled high blood pressure (systolic over 150 mm Hg or diastolic over 100 mm Hg)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

screening and enrollment visit

Surgery and Immediate Post-operative Care

Duration - Day of surgery and immediate recovery period

Participants undergo laparoscopic jejuno-ileal or jejuno-colic diversion surgery under general anesthesia. This involves creating an anastomosis between parts of the small intestine or between the jejunum and transverse colon.

1 visit (in-person) for surgery

Post-operative Follow-up

Duration - Up to 36 months after surgery

Participants have follow-up clinic visits to monitor recovery, assess adverse events, and conduct physical exams including weight and girth measurements. Blood work such as glycated hemoglobin (HbA1c) is also performed.

Follow-up visits at weeks 1, 2, 3 and months 1, 2, 3, 6, 12, 18, 24, 30, and 36 after surgery

Trial Site Locations

Total: 2 locations

1

University of Ostrava

Ostrava, Czechia, 70300

Actively Recruiting

2

University of Ostrava, Faculty of Medicine

Ostrava, Czechia

Completed

Loading map...

Research Team

J

Jana Soldánová

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

A Bilingual Virtually-based Intervention (PEDALL) for the Pr...

Acute Lymphoblastic Leukemia

Actively Recruiting

1 location

A Causative Role for Amylin in Diabetic Peripheral Neuropath...

Type2 Diabetes

Actively Recruiting

2 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

National, regional, and global trends in fasting plasma glucose and diabetes prevalence since 1980: systematic analysis of health examination surveys and epidemiological studies with 370 country-years and 2·7 million participants.

Goodarz Danaei, Mariel M Finucane, Yuan Lu...

https://pubmed.ncbi.nlm.nih.gov/21705069

Spectral peak frequency in low-frequency band in cross spectra of blood pressure and heart rate fluctuations in young type 1 diabetic patients.

N Honzíková, A Krtička, E Závodná...

https://pubmed.ncbi.nlm.nih.gov/22670692

Metabolic Surgery in the Treatment Algorithm for Type 2 Diabetes: a Joint Statement by International Diabetes Organizations.

Francesco Rubino, David M Nathan, Robert H Eckel...

https://pubmed.ncbi.nlm.nih.gov/27957699