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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayside Health
ClinicalTrials.gov Identifier:
NCT00422253
First received: January 11, 2007
Last updated: December 12, 2013
Last verified: January 2007

January 11, 2007
December 12, 2013
November 2006
December 2012   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00422253 on ClinicalTrials.gov Archive Site
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Dietary Advanced Glycation End-products and Insulin Resistance in Overweight and Obese Humans
Will Reduction in Dietary Advanced Glycation End- Products Reduce Chronic Low Grade Inflammation and Improve Insulin Sensitivity in Overweight and Obese Humans

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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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Prevention
  • Type 2 Diabetes
  • Insulin Resistance
  • Obesity
Behavioral: dietary intervention
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00422253
36/06
No
Bayside Health
Bayside Health
Not Provided
Principal Investigator: Barbora de Courten, MD PhD Baker Heart Research Institute
Bayside Health
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP