Trial Review

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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
Research Ethics and Governance Office The Lodge, Rankin Park Campus Lookout Road, New Lambton NSW 2305
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
The aim of this study is to define what is a normal blood glucose level post meal in people without diabetes. This study involves consuming five standardised test meals of varying macronutrient composition over five days. To assess the effect of each meal on post-meal blood glucose participant glucose levels will be measured continuously for 4 hours post- meal.
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
[email protected]
Contact person for public queries
Name 89935 0
Miss 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
[email protected]
Contact person for scientific queries
Name 89936 0
Miss 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
[email protected]

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.