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Type 2 DiabetesNCT00422253

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

A study testing dietary intervention in people with Type 2 Diabetes and Insulin Resistance, run by Bayside Health at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes, Insulin Resistance, Obesity
What is being tested?
dietary intervention
How many people
27 participants
Where
1 siteAustralia
Study dates
Nov 2006to Dec 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 11Show fewer
  • 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 locations and contacts

1 site in 1 country.

Australia1 site

  • Baker Heart Research Insitute

    Melbourne, Victoria, 3186

Other trials in Australia

About this study

Official title: Will Reduction in Dietary Advanced Glycation End- Products Reduce Chronic Low Grade Inflammation and Improve Insulin Sensitivity 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.

Keywords
insulin resistance, insulin secretion, advanced glycation end-products
Medical subject headings
Diabetes Mellitus, Type 2, Insulin Resistance, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2007 (estimated)
  2. Study startNov 2006
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00422253
Sponsor's protocol ID
36/06
Status last verified
Jan 2007
First submitted
11 Jan 2007
Last updated
16 Dec 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 28460575

  • 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.

    PubMed 27030534

  • 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.

    PubMed 26223897

Questions about this trial

What is this clinical trial studying?

A study testing dietary intervention in people with Type 2 Diabetes and Insulin Resistance, run by Bayside Health at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00422253, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2013.

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