Trial Review

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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 individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided 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.