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

Primary Purpose

Type 2 Diabetes, Insulin Resistance, Obesity

Status

Completed

Phase

Not Applicable

Locations

Australia

Study Type

Interventional

Intervention

dietary intervention

About this trial

This is an interventional prevention trial for Type 2 Diabetes focused on measuring insulin resistance, insulin secretion, advanced glycation end-products

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts 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

Sites / Locations

Baker Heart Research Insitute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00422253

First Posted

January 11, 2007

Last Updated

December 12, 2013

Sponsor

Bayside Health

1. Study Identification

Unique Protocol Identification Number

NCT00422253

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

January 2007

Overall Recruitment Status

Completed

Study Start Date

November 2006 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayside Health

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes, Insulin Resistance, Obesity

Keywords

insulin resistance, insulin secretion, advanced glycation end-products

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Single

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Behavioral

Intervention Name(s)

dietary intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Barbora de Courten, MD PhD

Organizational Affiliation

Baker Heart Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Baker Heart Research Insitute

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3186

Country

Australia

12. IPD Sharing Statement

Citations:

PubMed Identifier

28460575

Citation

Pearce K, Hatzinikolas A, Moran L, de Courten MPJ, Forbes J, Scheijen JLJM, Schalkwijk CG, Walker K, de Courten B. Disparity in the micronutrient content of diets high or low in advanced glycation end products (AGEs) does not explain changes in insulin sensitivity. Int J Food Sci Nutr. 2017 Dec;68(8):1021-1026. doi: 10.1080/09637486.2017.1319468. Epub 2017 May 2.

Results Reference

derived

PubMed Identifier

27030534

Citation

de Courten B, de Courten MP, Soldatos G, Dougherty SL, Straznicky N, Schlaich M, Sourris KC, Chand V, Scheijen JL, Kingwell BA, Cooper ME, Schalkwijk CG, Walker KZ, Forbes JM. Diet low in advanced glycation end products increases insulin sensitivity in healthy overweight individuals: a double-blind, randomized, crossover trial. Am J Clin Nutr. 2016 Jun;103(6):1426-33. doi: 10.3945/ajcn.115.125427. Epub 2016 Mar 30.

Results Reference

derived

PubMed Identifier

26223897

Citation

de Courten B, de Courten MP, Schalkwijk CG, Walker KZ, Forbes J. Dietary Advanced Glycation End Products Consumption as a Direct Modulator of Insulin Sensitivity in Overweight Humans: A Study Protocol for a Double-Blind, Randomized, Two Period Cross-Over Trial. JMIR Res Protoc. 2015 Jul 29;4(3):e93. doi: 10.2196/resprot.4552.

Results Reference

derived

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

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