Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000861459
Ethics application status
Approved
Date submitted
1/06/2016
Date registered
30/06/2016
Date last updated
5/10/2024
Date data sharing statement initially provided
20/10/2021
Date results provided
20/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Quantity of IV insulin required to keep blood glucose levels within target range after a high protein/high fat meal.
Scientific title
Insulin requirements to maintain post-prandial euglycaemia following consumption of a high protein/high fat meal
Secondary ID [1] 289336 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 298950 0
Condition category
Condition code
Inflammatory and Immune System 299023 299023 0 0
Autoimmune diseases
Metabolic and Endocrine 299024 299024 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves the provision of a meal high in both protein and fat. The high protein/high fat meal contains 30grams of carbohydrate, 60g protein and 40g of fat. There is a minimum of 1 week between the intervention and control meal. From the commencement of meal consumption, IV insulin will be titrated in response to the glucose excursions to keep BGL at a target of 5.5mmol.
Intervention code [1] 294897 0
Treatment: Other
Comparator / control treatment
The control is the provision of a meal low in protein and fat. The meal contains 30grams of carbohydrate, 5g protein and 5g of fat.
Control group
Active

Outcomes
Primary outcome [1] 298487 0
The total amount of IV insulin (units) titrated to maintain blood glcose levels at 5.5mmol/L after a high fat/high protein meal compared to a control meal.
Timepoint [1] 298487 0
5 hours after the commencement of the test meal
Secondary outcome [1] 324350 0
The change in serum assay levels of gastrointestinal hormones on consumption of high fat/high protein meal compared to control meal.
Timepoint [1] 324350 0
15- 60 minute intervals from 30 minutes prior to the consumption of the test meal up until 5 hours after the commencement of the test meal.

Eligibility
Key inclusion criteria
Type 1 diabetes > 1 year
HbA1c < /= 8%
Intesive insulin therapy > 6 months
BMI < /= 97th percentile
Minimum age
12 Years
Maximum age
21 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
pre-existing diabetes complications
co-existing medical conditions

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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/07/2016
Actual
25/07/2016
Date of last participant enrolment
Anticipated
31/12/2016
Actual
3/07/2017
Date of last data collection
Anticipated
Actual
17/07/2017
Sample size
Target
13
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 5868 0
Princess Margaret Hospital - Subiaco
Recruitment hospital [2] 5869 0
John Hunter Children's Hospital - New Lambton
Recruitment postcode(s) [1] 13310 0
6008 - Subiaco
Recruitment postcode(s) [2] 13311 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 293713 0
Charities/Societies/Foundations
Name [1] 293713 0
Juvenile Diabetes Research Fund
Country [1] 293713 0
Australia
Primary sponsor type
Hospital
Name
Princess Margaret Hospital
Address
Roberts Rd, Subiaco WA 6008
Country
Australia
Secondary sponsor category [1] 292546 0
Hospital
Name [1] 292546 0
John Hunter Children's Hospital
Address [1] 292546 0
Lookout Road, New Lambton NSW 2305
Country [1] 292546 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295168 0
Princess Margaret Hospital Human Research Ethics Committee
Ethics committee address [1] 295168 0
Ethics committee country [1] 295168 0
Australia
Date submitted for ethics approval [1] 295168 0
01/04/2016
Approval date [1] 295168 0
21/04/2016
Ethics approval number [1] 295168 0
2016049EP
Ethics committee name [2] 295169 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 295169 0
Ethics committee country [2] 295169 0
Australia
Date submitted for ethics approval [2] 295169 0
20/04/2016
Approval date [2] 295169 0
08/06/2016
Ethics approval number [2] 295169 0
16/05/18/4.02

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

Contacts
Principal investigator
Name 66298 0
Prof Elizabeth Davis
Address 66298 0
Princess Margaret Hospital
Diabetes and Endocrinology Department
GPO Box D184
perth
WA
6840
Country 66298 0
Australia
Phone 66298 0
+61 0864561111
Fax 66298 0
Email 66298 0
[email protected]
Contact person for public queries
Name 66299 0
Elizabeth Davis
Address 66299 0
Princess Margaret Hospital
Diabetes and Endocrinology Department
GPO Box D184
Perth
WA
6840
Country 66299 0
Australia
Phone 66299 0
+61864561111
Fax 66299 0
Email 66299 0
[email protected]
Contact person for scientific queries
Name 66300 0
Elizabeth Davis
Address 66300 0
Princess Margaret Hospital
Diabetes and Endocrinology Department
GPO Box D184
Perth
WA
6840
Country 66300 0
Australia
Phone 66300 0
+61864561111
Fax 66300 0
Email 66300 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.