Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000324910
Ethics application status
Not yet submitted
Date submitted
21/03/2011
Date registered
28/03/2011
Date last updated
5/11/2018
Date data sharing statement initially provided
5/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study of gastric bypass surgery in non-obese individuals with type 2 diabetes
Scientific title
Pilot study of gastric bypass surgery in non-obese individuals with type 2 diabetes
Secondary ID [1] 259825 0
Nil
Universal Trial Number (UTN)
U1111-1120-2186
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 265401 0
Condition category
Condition code
Metabolic and Endocrine 265560 265560 0 0
Diabetes
Surgery 265598 265598 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Modified gastric bypass operation performed by open laparotomy, under general anaesthetic. A small gastric pouch is created and joined directly to a Roux loop of jejunum, thus bypassing most of the stomach and the duodenum. Duration approx 3 hours.
Intervention code [1] 264253 0
Treatment: Surgery
Comparator / control treatment
no control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262365 0
Resolution of diabetes as judged by absence of need for medication and fasting blood sugar and HbA1c less than 7.
Timepoint [1] 262365 0
12 months
Secondary outcome [1] 273636 0
Improvement in diabetes control as judged by improvemnt in HbA1c and /or less medication
Timepoint [1] 273636 0
1 month, 3 months, 6 months, 9 months. 12 months
Secondary outcome [2] 273637 0
Improvement in insulin resistance, as judged by improvement in HOMA and/or hyperinsulinaemic euglycaemic clamp.
Timepoint [2] 273637 0
1 month, 3 months, 6 months, 9 months. 12 months

Eligibility
Key inclusion criteria
Type 2 diabetes > 1 year duration
HbA1c > 7.5 < 11%
BMI > 25 <30
HOMA > 4.0
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Poor risk for major surgery
major end-organ damage from diabetes
taking insulin
positive GAD or IA2 antibodies

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment outside Australia
Country [1] 3305 0
New Zealand
State/province [1] 3305 0

Funding & Sponsors
Funding source category [1] 264704 0
Charities/Societies/Foundations
Name [1] 264704 0
NZ Lottery Grants Board
Country [1] 264704 0
New Zealand
Funding source category [2] 264705 0
Self funded/Unfunded
Name [2] 264705 0
The Wakefield Clinic
Country [2] 264705 0
New Zealand
Funding source category [3] 264737 0
Other
Name [3] 264737 0
The Wakefield Clinic
Country [3] 264737 0
New Zealand
Primary sponsor type
Other
Name
The Wakefield Clinic
Address
PO Box 7366
Level 1, 121 Adelaide Rd,
Wellington
Country
New Zealand
Secondary sponsor category [1] 263862 0
None
Name [1] 263862 0
Address [1] 263862 0
Country [1] 263862 0
Other collaborator category [1] 251890 0
Individual
Name [1] 251890 0
Dr Jeremy Krebs
Address [1] 251890 0
Dept of Medicine Wellington Hospital Riddiford St Wellington 6242
Country [1] 251890 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 266699 0
Ethics committee address [1] 266699 0
Ethics committee country [1] 266699 0
Date submitted for ethics approval [1] 266699 0
22/04/2011
Approval date [1] 266699 0
Ethics approval number [1] 266699 0

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

Contacts
Principal investigator
Name 32365 0
Prof Prof Richard Stubbs
Address 32365 0
PO Box 7366 Level 1, 121 Adelaide Rd,
Country 32365 0
New Zealand
Phone 32365 0
+64 4 9012560
Fax 32365 0
Email 32365 0
[email protected]
Contact person for public queries
Name 15612 0
Prof Richard Stubbs
Address 15612 0
The Wakefield Clinic PB 7909 Wellington
Country 15612 0
New Zealand
Phone 15612 0
6443818100 Ext 5416
Fax 15612 0
Email 15612 0
[email protected]
Contact person for scientific queries
Name 6540 0
Prof Richard Stubbs
Address 6540 0
The Wakefield Clinic PB 7909 Wellington
Country 6540 0
New Zealand
Phone 6540 0
6443818100 Ext 5416
Fax 6540 0
Email 6540 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: NO data was collected. Trial was withdrawn before first participant was enrolled



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.