Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000432516
Ethics application status
Approved
Date submitted
22/09/2006
Date registered
6/10/2006
Date last updated
6/10/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Carbohydrate Distribution
Scientific title
A randomized crossover trial to investigate the effect of the distribution of carbohydrates over the day on postprandial glucose excursions in individuals with type 2 diabetes using continuous glucose monitoring for a 72 hour period.
Secondary ID [1] 307 0
Commonwealth Scientific Industrial Research Organisation (CSIRO): AD29F
Universal Trial Number (UTN)
Trial acronym
postprandial glucose
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetics with HbA1c greater than 6.5mmol/L 1404 0
Condition category
Condition code
Metabolic and Endocrine 1499 1499 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trial will consist of four treatments with 40% of the total energy from carbohydrate.
Treatment 1: Carbohydrates evenly distributed throughout the day.
Treatment 2: Carbohydrates (~ 64%) loaded at breakfast.
Treatment 3: Carbohydrates (~ 62%) loaded at lunch.
Treatment 4: Carbohydrates (~ 62%) loaded at dinner.
In the treatment 1, the carbohydrates will be evenly distributed across the day while the energy distribution for breakfast, lunch and dinner will be approximately 25%, 25% and 50% of total energy for the day which reflects what is commonly observed in Australia. The remaining three treatments (2,3&4 will contain a meal which is “loaded” with carbohydrates i.e. the majority of carbohydrates (~ 63%) consumed for the day are consumed in that meal. To enable this to occur, the energy level of the “loaded” breakfast and lunch meals will be increased by ~ 11% and the corresponding remaining meals reduced by ~ 6% relative to treatment 1 & 4.

Participants will be allocated the four treatments in a randomised order. Each 24 hour treatment will be repeated on three consecutive days (72 hours).
The CGMS (Continuous Glucose Monitoring system) sensor will be inserted on Monday afternoon. Participants will be free to consume food of their choice for the remained of the day and asked to fast from 8pm that evening. The following day they will commence a given treatment for 72 hours. They will then return to the clinic on Friday morning to have the CGMS sensor removed and the data downloaded to a computer. All food and dietary advice will be provided to aid compliance. This process will complete one treatment. The following Monday they will return to the clinic and the routine repeated. The study should be completed in four consecutive weeks.
Intervention code [1] 1371 0
Lifestyle
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 2070 0
Data from the CGMS (Continuous Glucose Monitoring System)
Timepoint [1] 2070 0
Continuously monitored and will be downloaded and analyzed. This is an acute study running for 72 hours. An average blood glucose value will be automatically recorded every 5 minutes while wearing the monitor.
Secondary outcome [1] 3571 0
1. Body height and mass. Body height will be measured using a stadiometer (SECA, Hamburg, Germany) and body mass will be measured using calibrated electronic digital scales (Mercury, AMZ 14, Tokyo, Japan).
Timepoint [1] 3571 0
This will be measured at the beginning and end of each treatment.
Secondary outcome [2] 3572 0
2.Weighed food records and time of eating episodes.
Timepoint [2] 3572 0
This will be recorded for the 72hour duration of each treatment.
Secondary outcome [3] 3573 0
3.VAS (Visual Analogue Scale)degree of hunger questionnaire: Participants will complete a Visual Analogue Scale degree of hunger questionnaire each hour the volunteer is awake.
Timepoint [3] 3573 0
This will be completed each waking hour on each treatment.
Secondary outcome [4] 3574 0
4.Blood measurements. Fasting plasma will be collected and sent to the Institute of Medical and Veterinary Science (IMVS) for analysis of HbA1c by high-performance liquid chromatography.
Timepoint [4] 3574 0
This will be measured at screening only.

Eligibility
Key inclusion criteria
Diagnosed with Type 2 Diabetes and have HAb1C greater than 6.5% (this will be tested)• Not have type 1 diabetes• Participants must understand the procedures involved and agree to participate in the study by giving full informed, written consent• No abnormality of clinical significance on medical history• If female, not pregnant or breast feeding.
Minimum age
30 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to maintain current supplements or drug use at a stable dose for the 4 week period. (We will accept volunteers taking metformin, but exclude those taking appetite suppressants). • Have a malignancy, or a 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)
Volunteers will be randomly allocated by computer generated sequence to study treatments. The treatments are coded alphabetically. Locked computer files indicate treatment allocation numerically and the treatment code is concealed from research staff.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random allocation using computer software clinstat
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/03/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1634 0
Government body
Name [1] 1634 0
Commonwealth Scientific Industrial Research Organisation
Country [1] 1634 0
Australia
Primary sponsor type
Government body
Name
Commonwealth Scientific Industrial Research Organisation, Human Nutrition
Address
Country
Australia
Secondary sponsor category [1] 1441 0
None
Name [1] 1441 0
n/a
Address [1] 1441 0
Country [1] 1441 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3080 0
CSIRO Human Nutrition
Ethics committee address [1] 3080 0
Ethics committee country [1] 3080 0
Australia
Date submitted for ethics approval [1] 3080 0
Approval date [1] 3080 0
15/02/2006
Ethics approval number [1] 3080 0
05/22

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27598 0
Address 27598 0
Country 27598 0
Phone 27598 0
Fax 27598 0
Email 27598 0
Contact person for public queries
Name 10560 0
Anne McGuffin
Address 10560 0
CSIRO Human Nutrition
PO Box 10041
Adelaide BC SA 5000
Country 10560 0
Australia
Phone 10560 0
+61 8 83038988
Fax 10560 0
+61 8 8303 8899
Email 10560 0
[email protected]
Contact person for scientific queries
Name 1488 0
Associate Prof Peter Clifton
Address 1488 0
CSIRO Human Nutrition
PO Box 10041
Adelaide BC SA 5000
Country 1488 0
Australia
Phone 1488 0
+61 8 83038826
Fax 1488 0
+61 8 8303 8899
Email 1488 0
[email protected]

No information has been provided regarding IPD availability


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.