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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00592735




Registration number
NCT00592735
Ethics application status
Date submitted
1/01/2008
Date registered
14/01/2008
Date last updated
7/06/2016

Titles & IDs
Public title
Effects of Medical and Surgical Weight Loss on Metabolism
Scientific title
The Role of Adipocyte-derived Inflammatory Cytokines in the Pathogenesis of Diabetes, Dyslipidaemia, Atherosclerosis and Gastro-oesophageal Reflux Disease: the Effects of Medical and Surgical Weight Loss
Secondary ID [1] 0 0
SVH H06/151
Secondary ID [2] 0 0
SVH H06/151
Universal Trial Number (UTN)
Trial acronym
BOS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 0 0
Obesity 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - laparoscopic gastric banding

1 -


Treatment: Surgery: laparoscopic gastric banding
standard surgical procedure
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
weight loss
Timepoint [1] 0 0
6 months

Eligibility
Key inclusion criteria
* morbidly obese subjects with type 2 diabetes or metabolic syndrome
* age <70
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* contra-indications to bariatric surgery

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2012
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St Vincent's Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Garvan Institute of Medical Research
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00592735