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Dietary Advanced Glycation End-products and Insulin Resistance in Overweight and Obese Humans

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ClinicalTrials.gov Identifier: NCT00422253
Recruitment Status : Completed
First Posted : January 15, 2007
Last Update Posted : December 16, 2013
Sponsor:
Information provided by (Responsible Party):
Bayside Health

Study Description
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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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Insulin Resistance Obesity Behavioral: dietary intervention Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Will Reduction in Dietary Advanced Glycation End- Products Reduce Chronic Low Grade Inflammation and Improve Insulin Sensitivity in Overweight and Obese Humans
Study Start Date : November 2006
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00422253


Locations
Australia, Victoria
Baker Heart Research Insitute
Melbourne, Victoria, Australia, 3186
Sponsors and Collaborators
Bayside Health
Investigators
Principal Investigator: Barbora de Courten, MD PhD Baker Heart Research Institute
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bayside Health
ClinicalTrials.gov Identifier: NCT00422253     History of Changes
Other Study ID Numbers: 36/06
First Posted: January 15, 2007    Key Record Dates
Last Update Posted: December 16, 2013
Last Verified: January 2007

Keywords provided by Bayside Health:
insulin resistance
insulin secretion
advanced glycation end-products

Additional relevant MeSH terms:
Overweight
Insulin Resistance
Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
 Metabolic Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs