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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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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)
Address [1] 3039 0
Private Bag 93311
Otahuhu
Auckland
Country [1] 3039 0
New Zealand
Funding source category [2] 3040 0
Charities/Societies/Foundations
Name [2] 3040 0
Middlemore Clinical Trials
Address [2] 3040 0
Private Bag 93311
Otahuhu
Auckland
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
Ministry of Health
Private Bag 92522
Auckland
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
The study comprises a randomised trial of intensive “wrap around” management versus standard guideline-based care. Sixty (60) patients with type 2 diabetes and morbid obesity (BMI = 35) will be enrolled. Patients will attend on average nine (9) scheduled study visits over the course of the study. Those found to be eligible after the baseline assessments will be randomised to receive a “wrap around” regimen comprising intensive psychological assessment/counselling, cultural support, intensive dietetic assessment/counselling and an exercise programme or standard guideline-based care in a 1:1 ratio. All participants (i.e. intensive management and standard care) will undergo a bariatric surgery procedure 6-months after randomisation. The total duration of follow-up is 18 months.
Trial website
Trial related presentations / publications
NA
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
brandon.or-walker@middlemore.co.nz
Contact person for public queries
Name 11499 0
Mrs 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
MWhite@middlemore.co.nz
Contact person for scientific queries
Name 2427 0
Dr 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
BOWalker@middlemore.co.nz

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