Australian BioEnterics Intragastric Balloon (BIB) study in obese subjects with metabolic syndrome
Active, not recruiting
- Conditions
- Obesity and associated metabolic syndrome, with or without other obesity-related co-morbiditiesMetabolic and Endocrine - Metabolic disorders
- Registration Number
- ACTRN12608000224325
- Lead Sponsor
- Allergan Australia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 66
Inclusion Criteria
(i) Body Mass Index (BMI) between 30 & 40 kg/m2 with metabolic syndrome (ii) Failed attempts to lose weight with supervised weight loss programmes
Exclusion Criteria
Specific Gastrointenstinal [GI] diseases/conditions (e.g. inflammatory; bleeding; dysmotility)
Prior gastric surgery; type 1 diabetes; untreated thyroid disease, hepatic or moderate to severe renal insufficiency; pregnancy; alcohol or drug dependence; psychiatric disorders; medication affecting weight or appetite
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method