A 12 month randomised controlled trial to determine whether a high egg versus low egg diet will lead to improved lipid levels in people with type 2 diabetes.

Australian Egg Corporation0 个研究点目标入组 140 人开始时间: 2012年12月4日最近更新: 2020年1月13日

适应症

试验速览

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•1. Aged 18 years or older
•2. Pre-diabetes or type 2 diabetes (based on bloods taken within 6 months of screening).
•To be eligible for the pre-diabetes criteria (based on ADA. Standards of Medical Care in Diabetes-2012. Diabetes Care 35, supp 1. January 2012”), participants must have:
•*a fasting plasma glucose greater than or equal to 5.6 mmol/L AND/OR
•*2 hour post-challenge (oral glucose tolerance test) plasma glucose greater than or equal to 7.8 mmol/L AND/OR
•*HbA1c greater than or equal to 5.7%
•3. BMI greater than or equal to '25 kg/m^2'
•The criteria for the diagnosis of type 2 diabetes will also be based on ADA. Standards of Medical Care in Diabetes-2012. Diabetes Care 35, supp 1. January 2012”.
•Participants must have:
•*a fasting plasma glucose greater than or equal to 7.0 mmol/L AND/OR
•*2 hour post-challenge (oral glucose tolerance test) plasma glucose greater than or equal to 11.1 mmol/L AND/OR
•*HbA1c greater than or equal to 6.5% AND/OR
•*When classic symptoms of hyperglycemia or hyperglycaemic crisis, a random plasma glucose greater than or equal to 11.1 mmol/

•1. Participants with type 2 diabetes and a HbA1c > 9.0%
•2. Vegetarian eating practices whereby eggs are avoided
•3. Known egg allergies
•4. Unstable angina or recent onset of cardiovascular disease (within 1 month of screening)
•5. Participants with prior gastric surgery or gastric banding
•6. A history of significant liver, kidney or gastrointestinal disease
•7. Untreated thyroid disease
•8. Alcohol or illicit drug abuse
•9. Pregnant, breastfeeding, or planning pregnancy during the study
•10. Use of weight loss medications and other drugs that affect body weight eg anti-psychotics, anti-depressants, or corticosteroids
•11. Participants who have commenced a new prescription medication within 3 months of screening or change in dose regimen of a prescription medication within 1 month of screening
•12. Participants with a history or presence of malignancy [completely resected basal or squamous cell carcinoma of the skin if treatment completed > 6 months prior to enrolment and participants in remission for > 5 years prior to screening are eligible]
•13. Inability to read and write English
•14. Participants who frequently change smoking habits or who have stopped smoking within 6 months prior to screening. Those who wish to take on the advice of a 'Quit' smoking program at the time of screening will be eligible to start the trial after 3 months

发起方

Australian Egg Corporation