Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000491864
Ethics application status
Approved
Date submitted
12/10/2011
Date registered
7/05/2012
Date last updated
7/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Glucose Tolerance Test Study
Scientific title
The effect of glucose on acute changes in circulating IL-6 concentrations in overweight individuals.
Secondary ID [1] 273204 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anti-inflammatory effect of insulin after Oral versus intravenous glucose in overweight individuals. 3010 0
Overweight/obesity 279037 0
Condition category
Condition code
Metabolic and Endocrine 3161 3161 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After fasting overnight 16 Participants will be given 75g glucose to take orally, at a seperate visit they will be given 75g glucose intravenously. As a control these participants will be given water. Following each 5 blood samples will be taken over a 2 hour period. There will be at least one week between each treatment.
Intervention code [1] 2750 0
Other interventions
Comparator / control treatment
Plasma inflammatory markers will be compared after oral glucose and Intravenous glucose with those measured after water (control).
Control group
Placebo

Outcomes
Primary outcome [1] 4045 0
Plasma level of IL-6 will be measured at 5 points after the glucose and water are given.
Timepoint [1] 4045 0
These levels will be measured in blood samples taken at 0, 30, 60, 90 and 120 minutes.
Secondary outcome [1] 6807 0
We will expand available information on the acute anti-inflammatory effect of insulin which may be important in limiting the inflammatory effect of food by measuring changes in plasma IL-6 levels.
Timepoint [1] 6807 0
proposed publication of results in peer reviewed journals 2012

Eligibility
Key inclusion criteria
BMI > 27kg/m2 , have no ongoing health problems, not have diabetes, take no medication.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Smoking, diabetes. Taking medications. BMI < 27kg/m2

Study design
Purpose of the study
Educational / counselling / training
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
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 862 0
New Zealand
State/province [1] 862 0
Otago

Funding & Sponsors
Funding source category [1] 3267 0
Charities/Societies/Foundations
Name [1] 3267 0
Healthcare Otago Charitable Trust
Country [1] 3267 0
New Zealand
Primary sponsor type
University
Name
Universtiy of otago
Address
Department of Medicine,
9th floor,
Dunedin hospital.
201 Great King Street
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 2921 0
None
Name [1] 2921 0
Address [1] 2921 0
Country [1] 2921 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5253 0
Lower South regional Ethics Committee
Ethics committee address [1] 5253 0
Ethics committee country [1] 5253 0
New Zealand
Date submitted for ethics approval [1] 5253 0
25/02/2008
Approval date [1] 5253 0
27/11/2008
Ethics approval number [1] 5253 0

Summary
Brief summary
Incretins are hormones that are produced in the intestine in response to food. The major increton is GLP-1 which directly stimulates the pancreas to produce insulin. The incretin effect is responsible for the greater insulin secretion seen after oral glucose intake compared to intravenous glucose. we postulate that after meal insulin changes are responsible for the reduction in circulating inflamatory marker IL-6 concentrations after an oral glucose tolerance test. If this is correct we believe that when the same amount of glucose is adminitered intravenously, due to a reduced insulin response, the after food decrease in IL-6 will be lessened.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28501 0
Address 28501 0
Country 28501 0
Phone 28501 0
Fax 28501 0
Email 28501 0
Contact person for public queries
Name 11658 0
Associate Professor Patrick manning
Address 11658 0
Department of Medicine,
9th floor,
Dunedin hospital.
201 Great King Street
Dunedin 9016
Country 11658 0
New Zealand
Phone 11658 0
64 3 4747007 ext 9146
Fax 11658 0
Email 11658 0
patrickmanning@healthotago.co.nz
Contact person for scientific queries
Name 2586 0
Dr. wayne sutherland phD
Address 2586 0
Department of Medicine,
9th floor,
Dunedin hospital.
201 Great King Street
Dunedin 9016
Country 2586 0
New Zealand
Phone 2586 0
64 3 4747007 ext 8512
Fax 2586 0
Email 2586 0
wayne.sutherland@stonebow.otago.ac.nz

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
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Documents added automatically
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