NCT00422253

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Nov 2006

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 15, 2007

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 16, 2013

Status Verified

January 1, 2007

Enrollment Period

6.1 years

First QC Date

January 11, 2007

Last Update Submit

December 12, 2013

Conditions

Type 2 DiabetesInsulin ResistanceObesity

Keywords

insulin resistanceinsulin secretionadvanced glycation end-products

Interventions

dietary interventionBEHAVIORAL

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baker Heart Research Insitute

Melbourne, Victoria, 3186, Australia

Location

Related Publications (3)

  • 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.

    PMID: 28460575DERIVED

  • 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.

    PMID: 27030534DERIVED

  • 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.

    PMID: 26223897DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin ResistanceObesity

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinismOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Barbora de Courten, MD PhD

    Baker Heart Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2007

First Posted

January 15, 2007

Study Start

November 1, 2006

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

December 16, 2013

Record last verified: 2007-01

Locations

AU(1)