None listed
Conditions
Brief summary
The aim of the study is to obtain an understanding of mechanisms of action and the biological and psychosocial effects of an Endoluminal Bariatric Intervention (Endobarrier-DJBS) in an obese diabetic population. Hypothesis: Implantation of the Endobarrier device will reduce: 1. Body weight as compared to the baseline values and compared to control interventions, 2. Intraluminal digestion of triglycerides as measures by the 13C triglyceride breath test in patients with EB device as compared to baseline and controls; 3. Fasting insulin and fasting glucose during the intervention and improvement will be greater in actively treated subjects. In addition the implantation of the Endobarrier device will: 4. Alter the mucosal and stool microbiome, 5. Improve liver function and parameters of fibrosis (elastography, blood tests, liver biopsy ). 6. Improve cardiopulmonary reserve and exercise capacity, 7. Improve quality of life, self-image, anxiety and depression will improve in actively treated subjects as compared to baseline.
Interventions
40 patients will be recruited for this study. All patients will have an Endobarrier device inserted. Endobarrier insertion occurs endoscopically by trained endoscopists and is fluoroscopically assisted for delivery to just below the pyloric sphincter where the device will settle and attach to the mucosa. The procedure takes approximately 45 minutes.
Following recruitment the patients will be randomised to either have an Endobarrier device inserted immediately (20 patients-Group “ETG-0”) or t
40 patients will be recruited for this study. All patients will have an Endobarrier device inserted. Endobarrier insertion occurs endoscopically by trained endoscopists and is fluoroscopically assisted for delivery to just below the pyloric sphincter where the device will settle and attach to the mucosa. The procedure takes approximately 45 minutes. Following recruitment the patients will be randomised to either have an Endobarrier device inserted immediately (20 patients-Group “ETG-0”) or to be treated with standard, conservative weight loss management. Those that did not immediately have a device inserted will be randomised again after 6 months. Half of these patients will then have a device inserted immediately (10 patients-Group “ETG-6”) or continue with standard conservative management for a total of 12 months before the device is inserted (10 patients- Group “ETG-12”) . The Endobarrier device will be removed after a maximum insertion period of 12 months.
Sponsors
Princess Alexandra Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Aged between 18 and 65 years. 2. Functional level equivalent to an ECOG score of 2 or less. 3. Obese – BMI over 35. 4. Type II diabetes mellitus on oral hypoglycaemic agents but not insulin. 5. English speaking. 6. Willing to participate in a 3 year trial and with capacity to consent.
Exclusion criteria
Exclusion criteria prior to recruitment will include: 1. Prior gastric or intestinal surgery including (not exclusively) the following: a. Nissen Fundoplication, gastrectomy, b. Vertical Banded Gastroplasty, Gastric Bypass, gastric partitioning, gastric stapling, gastric resection, placement of the LAPBAND (Trademark) System, c. Small bowel resection, colon resection, colostomy, d. Gynaecological surgery. 2. Any inflammatory disease of the gastrointestinal tract including oesophagitis, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn’s disease. 3. Potential upper gastrointestinal bleeding conditions such as oesophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses. 4. A large hiatal hernia. 5. A structural abnormality in the oesophagus or pharynx such as a stricture or diverticulum. 6. Significant coronary artery disease. (Previous myocardial infarction or angina in the past 90 days.) 7. Any medical condition that requires or is likely to require anticoagulation or dual anti-platelet therapy during the study period. 8. Any condition that requires the patient to take non-steroidal anti-inflammatory drugs during the study period. 9. Any active malignancy. 10. Any medical condition with a likely survival of 5 years or less. 11. Any patient likely to require abdominal surgery during the study period. 12. Patient or family history of connective tissue disease. 13. Known upper gastrointestinal abnormality. 14. Pregnancy. 15. Known chronic pancreatitis. 16. Poor functional status ECOG greater than or equal to 3. 17. Antibiotic use at the time of endoscopy. 18. Any other medical condition which would not permit elective endoscopy. 19. Major prior or present psychological disorder including alcoholism or drug addiction. Exclusion criteria after recruitment will include: 1. Inadequate cardiopulmonary reserve for anaesthetisation. 2. Structural or mucosal abnormality found during upper endoscopy that would preclude implantation. 3. Withdrawal of consent. 4. Clinician concern regarding any of the above exclusion criteria.
Outcome results
None listed