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

Purpose

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.

Condition	Intervention
Type 2 Diabetes Insulin Resistance Obesity	Behavioral: dietary intervention


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind Primary Purpose: Prevention
Official Title:	Will Reduction in Dietary Advanced Glycation End- Products Reduce Chronic Low Grade Inflammation and Improve Insulin Sensitivity in Overweight and Obese Humans

Resource links provided by NLM:

Drug Information available for: Insulin Insulin human

U.S. FDA Resources

Further study details as provided by Bayside Health:


Enrollment:	27
Study Start Date:	November 2006
Study Completion Date:	December 2012
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	18 Years to 50 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00422253

Locations


Australia, Victoria
Baker Heart Research Insitute
Melbourne, Victoria, Australia, 3186

Sponsors and Collaborators

Bayside Health

Investigators


Principal Investigator:	Barbora de Courten, MD PhD	Baker Heart Research Institute

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.


Responsible Party:	Bayside Health
ClinicalTrials.gov Identifier:	NCT00422253 History of Changes
Other Study ID Numbers:	36/06
Study First Received:	January 11, 2007
Last Updated:	December 12, 2013

Keywords provided by Bayside Health:


insulin resistance insulin secretion advanced glycation end-products

Additional relevant MeSH terms:


Overweight Insulin Resistance Body Weight Signs and Symptoms Hyperinsulinism Glucose Metabolism Disorders	Metabolic Diseases Insulin, Globin Zinc Insulin Hypoglycemic Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 23, 2017