Dietary Advanced Glycation End-products and Insulin Resistance 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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Key information

Conditions

Type 2 Diabetes Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baker Heart Research Insitute

Melbourne, Victoria, 3186, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary intervention

Behavioral

Sponsors and collaborators

Lead sponsor

Bayside Health

Other Gov

Registry information

Official study title

Will Reduction in Dietary Advanced Glycation End- Products Reduce Chronic Low Grade Inflammation and Improve Insulin Sensitivity in Overweight and Obese Humans

Important dates

Study start: 2006
Primary completion: 2012
Study completion: 2012
First posted: Jan 15, 2007
Registry last updated: Dec 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed