Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000331235
Ethics application status
Approved
Date submitted
13/11/2008
Date registered
22/05/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised crossover trial to investigate the effect of 2 different meals on diurnal blood glucose excursion
Scientific title
A randomised crossover trial to investigate the effect of a high carbohydrate versus a low carbohydrate breakfast on diurnal blood glucose excursion in Type 2 Diabetics.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
People with Type 2 diabetes ,20 peoplewith Glycated Haemaglobin (HbA1c)less than 7.0mmol/L and 20 people with HbA1c greater than 8 mmol/L 4065 0
Condition category
Condition code
Metabolic and Endocrine 4455 4455 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment 1 will contain 21% protein,28% fat and 51% carbohydrate this treatment will consist of 3 sandwich meals for breakfast lunch and dinner.Treatment 2 will contain 26% protein,40% fat and 34% carbohydrate,this treatment will consist of an omelette breakfast and a sandwich meal for lunch and dinner.At crossover there will be 5 days washout..Each treatment is one day.Treatment 1 and 2 are both a three meal a day treatment scheme.
Intervention code [1] 3786 0
Lifestyle
Comparator / control treatment
Treatment 2 will contain only 2grams of carbohydrate for breakfast,whereas lunch and dinner is exactly the same as lunch and dinner in treatment 1, 75gms.Breakfast,will differ in the two treatments
Control group
Active

Outcomes
Primary outcome [1] 5058 0
Data from Continuous Glucose monitoring System over 48 hours.
Timepoint [1] 5058 0
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 [1] 8510 0
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 .
Timepoint [1] 8510 0
On 2 occasions immediately after the standard lunch is consumed and continues for 6 hours until the third meal is consumed.

Eligibility
Key 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
Minimum age
30 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4981 0
Self funded/Unfunded
Name [1] 4981 0
Commonwealth Scientific Industrial Research Organisation
Country [1] 4981 0
Australia
Primary sponsor type
Government body
Name
Commonwealth Scientific Industrial Research Organisation
Address
Gate 13
Kintore Ave
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 4510 0
None
Name [1] 4510 0
Address [1] 4510 0
Country [1] 4510 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Currently fasting blood glucose (FBG) and glycated hemoglobin (HbA1c) are used to assess diabetes control. However high peak blood sugar levels after meals probably contribute more to the complications of diabetes than high average levels. There is very little known about the effects of meal composition and carbohydrate distribution on overall blood sugar control. This study will contribute to our understanding of the role of diet in the management of type 2 diabetes and help in the development of evidence based dietary guidelines regarding carbohydrate distribution.

To investigate the effect of three identical meals on diurnal blood glucose excursion,tretment 1,breakfast lunch and dinner.
To explore the effect of withholding carbohydrates at first meal after a prolonged (overnight) fast on the impact of carbohydrate ingestion at lunch time,treatment 2,breakfast lunch and dinner.Hence there are 2 arms to the study each diet is investigated for one full day.A gastric emptying breath test is performed on the first day in both weeks.
To determine the rate of gastric emptying when comparing a standard lunch following either a carbohydrate containing breakfast or a breakfast with no carbohydrate.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29120 0
Address 29120 0
Country 29120 0
Phone 29120 0
Fax 29120 0
Email 29120 0
Contact person for public queries
Name 12277 0
Julia Weaver
Address 12277 0
Gate 13 Kintore Ave Adelaide SA 5000
Country 12277 0
Australia
Phone 12277 0
+61 8 83038876
Fax 12277 0
Email 12277 0
[email protected]
Contact person for scientific queries
Name 3205 0
Associate Prof Peter Clifton
Address 3205 0
Commonwealth Scientific Industrial Research Organisation(CSIRO) Human Nutrition,Gate 13 Kintore Ave Adelaide SA 5000
Country 3205 0
Australia
Phone 3205 0
+61 8 83038800
Fax 3205 0
Email 3205 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.