Effects and Mechanisms of Action of an Endoscopically Placed Duodenal-Jejunal Sleeve Device (Endobarrier) in Obese Patients with Type II Diabetes

Phase 4

Terminated

• Conditions: Type 2 Diabetes Mellitus; Obesity; Metabolic and Endocrine - Diabetes; Diet and Nutrition - Obesity

• Registration Number: ACTRN12615001229561
• Lead Sponsor: Princess Alexandra Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-10
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified