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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00422253
Registration number
NCT00422253
Ethics application status
Date submitted
11/01/2007
Date registered
15/01/2007
Date last updated
16/12/2013
Titles & IDs
Public title
Dietary Advanced Glycation End-products and Insulin Resistance in Overweight and Obese Humans
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Scientific title
Will Reduction in Dietary Advanced Glycation End- Products Reduce Chronic Low Grade Inflammation and Improve Insulin Sensitivity in Overweight and Obese Humans
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Secondary ID [1]
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36/06
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes
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Insulin Resistance
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Obesity
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Condition category
Condition code
Diet and Nutrition
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Obesity
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Behaviour - dietary intervention
Behaviour: dietary intervention
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Intervention code [1]
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Behaviour
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Comparator / control treatment
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Control group
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Outcomes
Eligibility
Key inclusion criteria
- weight stable overweight and obese (BMI = 25kg/m2) non-diabetic individuals, aged
18-50 years and healthy according to medical history, blood biochemistry and physical
examination.
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Minimum age
18
Years
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Maximum age
50
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Participants will be excluded if they:
- are aged <18 years or > 50 years;
- currently smoke, have high alcohol use; or a positive urine drug screening test;
- have a history of: diabetes, cardiovascular and hematological disease,
respiratory, gastrointestinal, endocrine, renal or central nervous system
disease, psychosis or psychiatric disorder, active cancer within last 5 years.
- are actively seeking to lose weight, or if their weight has changed by more than
10 kilograms in the previous 12 months.
- have been taking medication within one month prior to commencing the study;
- have acute inflammation (by history, physical or laboratory examination)
- are on hormonal contraceptives, or pregnant (by HCG urine pregnancy screening
test) or lactating
- have highly unusual dietary habits or follow vegan diets (because of the
difficulty in complying with the assigned diet).
- have current diabetes (determined by history and/or 75g glucose OGTT)
- are unable to provide informed consent
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2012
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Sample size
Target
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Accrual to date
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Final
27
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Baker Heart Research Insitute - Melbourne
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Recruitment postcode(s) [1]
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3186 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Bayside Health
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
We hypothesize that reduction in dietary advance glycation endproducts (AGE) intake will
increase insulin sensitivity and normalise insulin secretion in overweight and obese
individuals through reduction of chronic low grade inflammation.
We propose to test this hypothesis by performing euglycemic hypeinsulinemic glucose clamp and
intravenous glucose tolerance test before and after low AGE diet and normal Australian diet
in a cross-over design. This study will provide information relevant to the development and
prevention of type 2 diabetes.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00422253
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Barbora de Courten, MD PhD
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Address
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Baker Heart Research Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00422253
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