EndoBarrier in Obese Subjects With Type 2 Diabetes Mellitus

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02769728
• Date of registration: 03/05/2016
• Prospective Registration: No
• Primary sponsor: Medical University of Graz
• Public title: EndoBarrier in Obese Subjects With Type 2 Diabetes Mellitus
• Scientific title: EndoBarrierTM in Obese Subjects With Type 2 Diabetes: Impact on Pancreatic Function, Insulin Resistance, Gut Peptides and Gut Permeability - a Pilot Study
• Date of first enrolment: February 2016
• Target sample size: 10
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02769728
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Austria

Contacts

• Name: Harald Sourij, MD
• Affiliation: Medical University of Graz, Auenbruggerplatz 15

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participant is willing and able to give informed consent for participation in the
study.

- Type 2 diabetes

- BMI 30-49 kg/m²

- HbA1c = 6.5% (48 mmol/mol)

- Appropriate life style intervention measures have been tried but have failed to
achieve or maintain adequate, clinically beneficial weight loss for at least 6 months

- Person is generally fit for intervention

- Person commits to the need for long-term follow-up

Exclusion Criteria:

- Type 1 diabetes mellitus

- Maturity Onset Diabetes of the Young (MODY)

- Secondary diabetes due to a specific disease or glucocorticoid therapy

- Pregnancy or women of childbearing age without adequate contraception

- Women who are breast-feeding

- Hypothalamic cause of obesity, Cushing syndrome

- Major psychiatric disease including diagnosed eating disorders, history of drug or
alcohol abuse

- History of bariatric surgery or complex abdominal surgery

- Inflammatory bowel disease

- Pancreatitis

- Cholelithiasis

- Uncontrolled gastroesophageal reflux

- Known upper GI bleeding conditions, e.g. gastric or esophageal varices

- Congenital or acquired abnormalities of the upper GI tract, e.g. stenosis

- Subjects with or a history of coagulopathy, upper gastro-intestinal bleeding
conditions such as esophageal or gastric varices, congenital or acquired intestinal
telangiectasia

- Chronic non-steroidal anti-inflammatory drug (NSAID) or aspirin treatment (Subjects
unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the
implant period)

- Previous GI surgery that could affect the ability to place the device or the function
of the implant

- GLP-1 receptor agonist therapy

- Known ischaemic heart disease or heart failure

- History of stroke

- Active Helicobacter pylori (Note: Subjects may be enrolled if they had a prior history
of Helicobacter Pylori and were successfully treated)

- Iron deficiency and/or iron deficiency anemia

- Subjects or Family history of a known diagnosis or pre-existing symptoms of systemic
lupus erythematosus, scleroderma or other autoimmune connective tissue disorder

- Known malignancy or any other multimorbid patient condition or circumstance, which, in
the opinion of the investigator, would affect the patient's ability to participate in
the protocol or would put the participant at an unjustified risk



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Type 2 Diabetes

Obesity

Intervention(s)

Device: EndoBarrier

Primary Outcome(s)

Changes in insulin sensitivity [Time Frame: 9 months]

Secondary Outcome(s)

Changes in cardiovascular risks [Time Frame: 9 months]

Changes in gut permeability [Time Frame: 9 months]

Changes in gut microbiota [Time Frame: 9 months]

Changes in beta-cell function [Time Frame: 9 months]

Changes in Glucagon like peptide -1 levels [Time Frame: 9 months]

Weight loss [Time Frame: 9 months]

Secondary ID(s)

HS-2014-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors