A randomised crossover trial to investigate the effect of 2 different meals on diurnal blood glucose excursio
Not Applicable
Recruiting
- Conditions
- People with Type 2 diabetes ,20 peoplewith Glycated Haemaglobin (HbA1c)less than 7.0mmol/L and 20 people with HbA1c greater than 8 mmol/LMetabolic and Endocrine - Diabetes
- Registration Number
- ACTRN12609000331235
- Lead Sponsor
- Commonwealth Scientific Industrial Research Organisation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Weight stable,diagnosed with Type 2 diabetes,HbA1c, 7 for half the sample and HbA1c .8 for the other half of the sample.Treated with diet or stable on oral therapy for at least 3 months.No abnormality of clinical significance on medical history.Participants must understand the procedures involved and agree to participate in the study by giving full informed written consent
Exclusion Criteria
Type 1 diabetes or insulin treated Type 2 diabetes.Have a malignancy or history of metabolic disease such as liver kidney or gastrointestinal disease.Inability to prepare meals or meet diet requirements,Unable to comprehend or cope with study requirements.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Data from Continuous Glucose monitoring System over 48 hours.[Monitoring will take place immediately once the first meal test commences and it will continue for 48 hours until the second meal test is completed. After 5 days washout this will be repeated.]
- Secondary Outcome Measures
Name Time Method Results from Gastric emptying breath testing on 2 occasions after the standard lunch is consumed for both treatments preceded by the different breakfast meal patterns.The test will last 6 hours .[On 2 occasions immediately after the standard lunch is consumed and continues for 6 hours until the third meal is consumed.]