Small Bowel Diversion

Launched by UNIVERSITY OF OSTRAVA · Apr 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two new surgical methods designed to help individuals with obesity and Type 2 diabetes. These methods create a connection between different parts of the small intestine, allowing food to take a shorter route through the digestive system. This shorter route may help people lose weight and improve their blood sugar levels by changing how the body processes food, while also reducing some risks associated with traditional metabolic surgeries.

To participate in this trial, individuals should be between 18 and 65 years old, have a body mass index (BMI) between 30 and 50, and if they have Type 2 diabetes, their blood sugar levels need to meet specific criteria. Participants can expect to undergo a procedure that aims to improve their health outcomes without some of the risks of more invasive surgeries. It's also important to note that this trial is currently active but not recruiting new participants at this time, and some individuals may not be eligible due to certain medical conditions or history.

Gender

ALL

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).