Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000080325
Ethics application status
Approved
Date submitted
30/01/2008
Date registered
13/02/2008
Date last updated
10/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Bariatric Surgery in Morbidly Obese Type 2 Diabetic Patients
Scientific title
A randomised trial of adjunction intensive psychological, dietary and cultural management versus standard guidelines-based care to maximise weight loss among high-risk subjects with type 2 diabetes mellitus and morbid obesity treated with bariatric surgery
Secondary ID [1] 289910 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 2800 0
Morbid Obesity 2801 0
Condition category
Condition code
Other 2911 2911 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intensive “wrap around” regimen comprising intensive psychological assessment/counselling, cultural support, intensive dietetic assessment/counselling and an exercise programme. The duration of this intervention is 6 months pre-operatively and 12 months post-operatively. The exact nature of the regimen will be tailored to the participant on a case by case basis.
Intervention code [1] 2519 0
Treatment: Other
Comparator / control treatment
Standard guideline-based care comprising of post surgical clinic follow-up.
Control group
Active

Outcomes
Primary outcome [1] 3794 0
Change in body mass index (BMI).
Timepoint [1] 3794 0
12 months after surgery.
Secondary outcome [1] 6401 0
Change in HbA1c as measured by a blood test.
Timepoint [1] 6401 0
1 year after surgery.

Eligibility
Key inclusion criteria
Type 2 diabetes
Morbid Obesity - BMI >35
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diabetic nephropathy.
A significant malabsorptive or gastrointestinal disorder.

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
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2008
Actual
22/05/2008
Date of last participant enrolment
Anticipated
Actual
20/05/2009
Date of last data collection
Anticipated
7/12/2011
Actual
7/12/2011
Sample size
Target
60
Accrual to date
Final
68
Recruitment outside Australia
Country [1] 776 0
New Zealand
State/province [1] 776 0

Funding & Sponsors
Funding source category [1] 3039 0
Hospital
Name [1] 3039 0
Counties Manukau District Health Board (CMDHB)
Country [1] 3039 0
New Zealand
Funding source category [2] 3040 0
Charities/Societies/Foundations
Name [2] 3040 0
Middlemore Clinical Trials
Country [2] 3040 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Middlemore Clinical Trials
Address
Private Bag 93311
Otahuhu
Auckland
Country
New Zealand
Secondary sponsor category [1] 2740 0
None
Name [1] 2740 0
Address [1] 2740 0
Country [1] 2740 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295709 0
Northern X Regional Ethics Committee
Ethics committee address [1] 295709 0
Ethics committee country [1] 295709 0
New Zealand
Date submitted for ethics approval [1] 295709 0
10/10/2007
Approval date [1] 295709 0
11/01/2008
Ethics approval number [1] 295709 0
NTX/07/06/053

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

Contacts
Principal investigator
Name 28342 0
Dr Brandon Orr Walker
Address 28342 0
Middlemore Hospital
100 Hospital Rd
Auckland 2025
Country 28342 0
New Zealand
Phone 28342 0
+64 9 2760000
Fax 28342 0
Email 28342 0
[email protected]
Contact person for public queries
Name 11499 0
Marie White
Address 11499 0
CCRep
Private Bag 93311
Otahuhu
Auckland
Country 11499 0
New Zealand
Phone 11499 0
+64 9 276 0044 extn 2275
Fax 11499 0
Email 11499 0
[email protected]
Contact person for scientific queries
Name 2427 0
Brandon Orr-Walker
Address 2427 0
Middlemore Hospital
Private Bag 93311
Otahuhu
Auckland
Country 2427 0
New Zealand
Phone 2427 0
+64 9 276 0044 extn 8068
Fax 2427 0
Email 2427 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.