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Trial registered on ANZCTR


Registration number
ACTRN12619000082101p
Ethics application status
Submitted, not yet approved
Date submitted
14/01/2019
Date registered
21/01/2019
Date last updated
21/01/2019
Date data sharing statement initially provided
21/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Glucose Responses to Normal Meals In Non-diabetic Individuals
Scientific title
Defining the postprandial glycaemic response to normal meals in healthy, non-diabetic individuals
Secondary ID [1] 297059 0
Non
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 311062 0
Condition category
Condition code
Metabolic and Endocrine 309698 309698 0 0
Diabetes
Diet and Nutrition 309699 309699 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study involves the provision of five standardised test meals of varying macronutrient composition, 4 breakfast meals (see below) and 1 dinner meal (pizza, Carbohydrate:76g, Fat:45g, Protein:55g) to be consumed over five days (inclusive of a 24 hour washout period between intervention). Test meals must be consumed in their entirety within 20 minutes. Test meals will be randomised to days using a block design. To assess the effect of each meal on postprandial glycaemia participant interstitial glucose levels will be measured continuously for 4 hours post- meal consumption using a continuous glucose monitor.

breakfast meals
1. Carbohydrate:30g, Fat: less than 10g, Protein: less than 10g (toast with butter)
2.Carbohydrate:30g, Fat:40g, Protein: less than 10g (cheesecake muffin)
3.Carbohydrate:30g, Fat: less than 10g, Protein: 50g (protein milkshake)
4. Carbohydrate:30g, Fat:40g, Protein: 50g (protein milkshake with muesli bar)
Intervention code [1] 313334 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Active

Outcomes
Primary outcome [1] 318665 0
The primary outcome variable of this study is the mean postprandial glucose excursion. Participant glucose levels will be monitored continuously for four hours post meal consumption using a continuous glucose monitor.
Timepoint [1] 318665 0
30-minute interval from baseline (t=0) to 240 minutes post- test meal consumption.
Secondary outcome [1] 365620 0
Mean peak postprandial glucose excursion
Timepoint [1] 365620 0
At the four hour assessment period
Secondary outcome [2] 365621 0
Mean time to peak postprandial glucose excursion
Timepoint [2] 365621 0
Peak interstitial glucose level will be assessed by continuously measuring interstitial glucose for 4- hours post-meal consumption
Secondary outcome [3] 365622 0
Mean time taken to return to baseline glucose level.
Timepoint [3] 365622 0
At the four hour assessment period
Secondary outcome [4] 365625 0
% time in postprandial euglycaemia (sensor glucose < 7.8 mmol/L)
Timepoint [4] 365625 0
Assessed continuously for four hours post-meal consumption
Secondary outcome [5] 365626 0
% time in postprandial hyperglycaemia (sensor glucose greater than 7.8 mmol/L)
Timepoint [5] 365626 0
Assessed continuously for four hours post meal consumption

Eligibility
Key inclusion criteria
• HbA1c less than or equal to 5.6% (37.7 mmol/mol) (capillary)
• Fasting blood glucose less than or equal to 5.5 mmol/L (capillary)
• Non- obese [BMI less than 95th percentile (less than or equal to 20 years) or BMI less than 30 kg/m2 (greater than 20 years)]
Minimum age
10 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Pre- diabetic or diabetic (as defined in the American Diabetes Association Standards of Medical Care in Diabetes, 2018)
• Allergies or intolerances that would prevent test meal consumption e.g Coeliac Disease
• Medications that may alter glycaemia
• Any other major medical condition

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)
None
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised Block Design
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Differences in mean interstitial glucose excursions between meal groups at a single time- point will be tested using a generalised linear mixed model with interstitial glucose excursion as the outcome of interest and insulin regime as the only predictor variable in the model (i.e. using a linear regression model but allowing for the correlation of repeated measurements on the same subjects).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/02/2019
Actual
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
31/01/2020
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 12878 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 12879 0
John Hunter Children's Hospital - New Lambton
Recruitment postcode(s) [1] 25356 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 301631 0
Charities/Societies/Foundations
Name [1] 301631 0
John Hunter Charitable Trust
Country [1] 301631 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
John Hunter Charitable Trust
Address
Lookout Rd, New Lambton Heights NSW 2305
Country
Australia
Secondary sponsor category [1] 301335 0
None
Name [1] 301335 0
N/A
Address [1] 301335 0
N/A
Country [1] 301335 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 302354 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 302354 0
Ethics committee country [1] 302354 0
Australia
Date submitted for ethics approval [1] 302354 0
30/11/2018
Approval date [1] 302354 0
Ethics approval number [1] 302354 0

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

Contacts
Principal investigator
Name 89934 0
Dr Carmel Smart
Address 89934 0
Department of Paediatric Endocrinology, Level 2, John Hunter Children's Hospital, Lookout Rd, New Lambton Heights, NSW, AUS, 2305
Country 89934 0
Australia
Phone 89934 0
+612 4042 0671
Fax 89934 0
Email 89934 0
Carmel.Smart@hnehealth.nsw.gov.au
Contact person for public queries
Name 89935 0
Tenele Smith
Address 89935 0
Department of Paediatric Endocrinology, Level 2, John Hunter Children's Hospital, Lookout Rd, New Lambton Heights, NSW, AUS, 2305
Country 89935 0
Australia
Phone 89935 0
+612 4042 0848
Fax 89935 0
Email 89935 0
tenele.smith@newcastle.edu.au
Contact person for scientific queries
Name 89936 0
Tenele Smith
Address 89936 0
Department of Paediatric Endocrinology, Level 2, John Hunter Children's Hospital, Lookout Rd, New Lambton Heights, NSW, AUS, 2305
Country 89936 0
Australia
Phone 89936 0
+612 4042 0848
Fax 89936 0
Email 89936 0
tenele.smith@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.