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

B

Bayside Health

Status

Completed

Conditions

Insulin Resistance
Obesity
Type 2 Diabetes

Treatments

Behavioral: dietary intervention

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

27 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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