Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000679280
Ethics application status
Not yet submitted
Date submitted
5/08/2009
Date registered
10/08/2009
Date last updated
10/08/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of weight reducing surgery on diabetes and the heart
Scientific title
Assessment of gut hormones and metabolic risk factors in patients with type 2 diabetes and obesity undergoing bariatric surgery
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 243462 0
type 2 diabetes 243463 0
Condition category
Condition code
Metabolic and Endocrine 239762 239762 0 0
Diabetes
Diet and Nutrition 239774 239774 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
patients with type2 diabetes and obesity undergoing gastric sleeve resection and gastric bypass bariatric surgery. This is a prospective study where observation will be made on 2 groups of patients: (1) those scheduled for gastric sleeve resection surgery (2)those scheduled for gastric bypass bariatric surgery.

gastric sleeve resection is carried out by a one off laparoscopic technique of about 90minutes. under general anaethesia.

gastric bypass is also performed laparoscopically which takes about 120-150minutes. under general anaethesia.

Comparison will be made with control group (patients scheduled for elective laparoscopic cholecystectomy)

observation period until 6 months post surgery
Intervention code [1] 237076 0
Treatment: Surgery
Comparator / control treatment
patients underoing elective laparoscopic cholecystectomy
Control group
Active

Outcomes
Primary outcome [1] 240524 0
blood tests after oral glucose: analysis of glucagon-like peptide 1 (GLP-1), ghrelin, glucagon, free fatty acids, glucose, insulin, C peptide
Timepoint [1] 240524 0
3 days before surgery, 3 days after surgery, 3 months after surgery, 6 months after surgery.
Primary outcome [2] 240525 0
continuous glucose monitoring in the perioperative phase using a continuous blood glucose monitor
Timepoint [2] 240525 0
from morning of surgery until day of discharge or day 6 post surgery (whichever occurs earlier)
Primary outcome [3] 240526 0
anthropometric data - height, weight, body mass index (BMI), hip waist circumference ratio. Blood pressure
Timepoint [3] 240526 0
3 days before surgery, 3 days after surgery, 3 months after surgery, 6 months after surgery.
Secondary outcome [1] 257079 0
metabolic risk factors:

by blood analysis: sensitive C-reactive protein (CRP), urate, lipids, Haemoglobin A1c (HbA1c),

urine analysis: to test for urine microalbumin
Timepoint [1] 257079 0
3 days before surgery, 3 days after surgery, 3 months after surgery, 6 months after surgery.
Secondary outcome [2] 257080 0
Quality of life assessment using Impact of Weight on Quality of Life-Lite (IWQOL-lite) questionnaire
Timepoint [2] 257080 0
3 days before surgery, 3 days after surgery, 3 months after surgery, 6 months after surgery.
Secondary outcome [3] 257081 0
simple calorimetry to assess energy expenditure
Timepoint [3] 257081 0
3 days before surgery, 3 days after surgery, 3 months after surgery, 6 months after surgery.
Secondary outcome [4] 257116 0
body composition analysis to assess fat and lean muscle mass using whole body dual X-ray absorptiometry
Timepoint [4] 257116 0
3 days before surgery, 3 days after surgery, 3 months after surgery, 6 months after surgery.

Eligibility
Key inclusion criteria
Inclusion criteria:
1. patients with type 2 diabetes or impaired glucose tolerance planned to have gastric bypass surgery at Auckland hospital
2. patients with type 2 diabetes or impaired glucose tolerance planned to have gastric sleeve resection at Middlemore hospital
3. Patients with type 2 diabetes or impaired glucose tolerance planned to have elective laparoscopic cholecystectomy (will required to be matched for BMI and age for cases in study)
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
1. Age <18, or >70
2. BMI < 35 kg/m2
3. Cardiovascular conditions including significant coronary artery disease, congestive heart failure
4. Severe pulmonary disease
5. Previous bariatric/gastric/small bowel operation.
6. Underlying endocrinology disorder or genetic syndrome related to obesity and secondary diabetes.
7. Steroid dependence
8. Exenatide treatment within 3 months of surgery
9. Previous surgery to pancreas, or other pancreatic pathology
10. Pregnant women

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)
Patient allocation is not performed as part of this project. Patients are selected from those whose surgical decision has already been made and scheduled for a particular elective surgical procedure (for our project: gastric sleeve resection, gastric bypass surgery, laparoscopic cholecystectomy)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 1935 0
New Zealand
State/province [1] 1935 0

Funding & Sponsors
Funding source category [1] 237451 0
Hospital
Name [1] 237451 0
Auckland Hospital A+ trust project grant
Country [1] 237451 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 236940 0
Hospital
Name [1] 236940 0
Auckland City Hospital
Address [1] 236940 0
Private Bag 92024
Auckland Mail Centre
Auckland 1142
Country [1] 236940 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 239579 0
Ethics committee address [1] 239579 0
Ethics committee country [1] 239579 0
Date submitted for ethics approval [1] 239579 0
10/08/2009
Approval date [1] 239579 0
Ethics approval number [1] 239579 0

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

Contacts
Principal investigator
Name 30013 0
Address 30013 0
Country 30013 0
Phone 30013 0
Fax 30013 0
Email 30013 0
Contact person for public queries
Name 13260 0
Shelley Yip
Address 13260 0
Rm 12083
Level 12 Support building
Auckland City hospital
Private Bag 92019
Auckland 1142
New Zealand
Country 13260 0
New Zealand
Phone 13260 0
+64211017436
Fax 13260 0
Email 13260 0
[email protected]
Contact person for scientific queries
Name 4188 0
Shelley Yip
Address 4188 0
Rm 12083
Level 12 Support building
Auckland City hospital
Private Bag 92019
Auckland 1142
New Zealand
Country 4188 0
New Zealand
Phone 4188 0
+64211017436
Fax 4188 0
Email 4188 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.