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Trial registered on ANZCTR


Registration number
ACTRN12608000224325
Ethics application status
Approved
Date submitted
23/04/2008
Date registered
30/04/2008
Date last updated
17/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Australian BioEnterics Intragastric Balloon (BIB) study in obese subjects with metabolic syndrome
Scientific title
A prospective, randomised, open-label, controlled study of safety and efficacy of the BioEnterics Intragastric Balloon (BIB) system in the treatment of obese participants with metabolic syndrome, with or without other obesity-related co-morbidities
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity and associated metabolic syndrome, with or without other obesity-related co-morbidities 3046 0
Condition category
Condition code
Metabolic and Endocrine 3225 3225 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Non-surgical intervention with intragastric balloon inserted into the stomach under endoscopic visualisation for a total of 6 months, as an adjunct to a 12 month behavioural management programme of supervised diet and exercise (A balanced diet high in whole grains, fruit and vegetables and with reduced fat intake. A moderate exercise regimen of at least 30 minutes/day will be instituted. This programme will be individualised and assessed each month by the study dietitian and the study exercise physiologist and will be amended as required)
Intervention code [1] 2813 0
Treatment: Devices
Comparator / control treatment
12 month behavioural management programme (supervised diet & exercise)
Control group
Active

Outcomes
Primary outcome [1] 4108 0
Relative % weight reduction from baseline for the two treatment groups
Timepoint [1] 4108 0
Month 6
Secondary outcome [1] 6922 0
% with a resolution of metabolic syndrome (defined as < 3 criteria from the 3rd Report of the National Cholesterol Education Program's Adult Treatment Panel [ATP III], which defines metabolic syndrome on the basis of fasting plasma glucose & triglyceride levels; waist circumference; HDL-cholesterol levels & blood pressure)
Timepoint [1] 6922 0
Months 0, 3, 6, 9 & 12
Secondary outcome [2] 6975 0
% achieving a reduction in body weight of > 10%
Timepoint [2] 6975 0
Months 0, 3, 6, 9 & 12
Secondary outcome [3] 6976 0
% with improvement or resolution of other obesity-related co-morbidities (including systemic hypertension; type 2 diabetes; & dyslipidaemia, which will be defined by improvement or normalisation of blood pressure, with reduction or discontinuation of antihypertensives; improvement or normalisation of biochemical markers with with reduction or discontinuation of anti-diabetic agents and improvement or normalisation of biochemical markers, respectively
Timepoint [3] 6976 0
Months 0, 3, 6, 9 & 12
Secondary outcome [4] 6977 0
Change in exercise tolerance (6 minute walk test)
Timepoint [4] 6977 0
Months 0, 3, 6, 9 & 12
Secondary outcome [5] 6978 0
Change in quality of life/health status (Impact of Weight on Quality of Life [IWQOL] Questionnaire, Assessment of Quality of Life [AQOL] Questionnaire, Beck Depression Inventory [BDI])
Timepoint [5] 6978 0
Months 0, 3, 6, 9 & 12

Eligibility
Key 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
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3319 0
Commercial sector/Industry
Name [1] 3319 0
Allergan Australia
Address [1] 3319 0
77 Ridge Street,
Gordon NSW 2072
Country [1] 3319 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Allergan Australia
Address
810 Pacific Highway, Level 4, Gordon NSW 2072
Country
Australia
Secondary sponsor category [1] 2950 0
None
Name [1] 2950 0
Address [1] 2950 0
Country [1] 2950 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28525 0
Address 28525 0
Country 28525 0
Phone 28525 0
Fax 28525 0
Email 28525 0
Contact person for public queries
Name 11682 0
Nick Fuller
Address 11682 0
Metabolism & Obesity Research
Level 12, Page Building (14)
Royal Prince Alfred Hospital (RPAH)
Missenden Road. Camperdown NSW 2050
Country 11682 0
Australia
Phone 11682 0
+61 2 9515 3685
Fax 11682 0
Email 11682 0
nick.fuller@sswahs.nsw.gov.au
Contact person for scientific queries
Name 2610 0
Michael Halstead
Address 2610 0
810 Pacific Highway, Level 4, Gordon NSW 2072
Country 2610 0
Australia
Phone 2610 0
+61 2 9498-0167
Fax 2610 0
+61 2 9498-0184
Email 2610 0
halstead_michael@allergan.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary