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
|
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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 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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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00422253
Australia, Victoria | |
Baker Heart Research Insitute | |
Melbourne, Victoria, Australia, 3186 |
Principal Investigator: | Barbora de Courten, MD PhD | Baker Heart Research Institute |
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 |