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

Not Applicable

Completed

• Conditions: Type 2 Diabetes; Insulin Resistance; Obesity

• Registration Number: NCT00422253
• Lead Sponsor: Bayside Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Status Verified: 2007-01
• Study First Submitted: 2007-01-11
• Study First Submitted QC: 2007-01-11
• Study First Posted: 2007-01-15
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2013-12-12
• Last Update Posted: 2013-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Trial Locations

Locations (1)

Baker Heart Research Insitute; 🇦🇺 Melbourne, Victoria, Australia