Are eggs good for people with type 2 diabetes?

Not Applicable

Completed

• Conditions: Type 2 diabetes; Diet and Nutrition - Obesity; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12612001266853
• Lead Sponsor: Australian Egg Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-12-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

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/

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine whether a high egg diet will lead to improved lipid levels (higher high density lipoprotein cholesterol, HDL-C) in people with pre or type 2 diabetes mellitus (T2DM). If so, then this research will help to dispel the notion that eggs are bad for people with T2DM. Bloods will be collected every 3 months and measured by serum assay.[12 months]