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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Bayside Health.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Bayside Health
ClinicalTrials.gov Identifier:
NCT00422253
First received: January 11, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  Purpose

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 Intervention
Type 2 Diabetes
Insulin Resistance
Obesity
 Behavioral: dietary intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayside Health:

Estimated Enrollment: 40
Study Start Date: November 2006
Estimated Study Completion Date: December 2008
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00422253

Contacts
Contact: Barbora de Courten, MD PhD +61385321353 Barbora.deCourten@baker.edu.au

Locations
Australia, Victoria
Baker Heart Research Insitute Recruiting
Melbourne, Victoria, Australia, 3186
Contact: Barbora de Courten, MD PhD     +61385321353     Barbora.deCourten@baker.edu.au    
Principal Investigator: Barbora de Courten, MD PhD            
Sponsors and Collaborators
Bayside Health
Investigators
Principal Investigator: Barbora de Courten, MD PhD Baker Heart Research Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00422253     History of Changes
Other Study ID Numbers: 36/06
Study First Received: January 11, 2007
Last Updated: January 11, 2007
Health Authority: National Health and Medical Research Council: Australia

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

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Insulin Resistance
Obesity
Overweight
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
 Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013