Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001127594
Ethics application status
Approved
Date submitted
7/09/2015
Date registered
26/10/2015
Date last updated
20/10/2021
Date data sharing statement initially provided
20/10/2021
Date results provided
20/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dietary proteins influence on post meal insulin requirements in young people with type 1 diabetes.
Scientific title
Effect of high protein meal on the insulin dose required to maintain post-prandial euglycaemia, in youth (12-21 years) with type 1 diabetes.
Secondary ID [1] 287076 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 295578 0
Condition category
Condition code
Inflammatory and Immune System 295853 295853 0 0
Autoimmune diseases
Metabolic and Endocrine 296543 296543 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves the provision of a meal high in protein. The high protein meal contains 30grams of carbohydrate, 60g protein and < 10g 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 5.0mmol.
Intervention code [1] 292900 0
Treatment: Other
Comparator / control treatment
The control is the provision of a meal low in protein. The meal contains 30grams of carbohydrate, 5g protein and < 10g of fat.
Control group
Active

Outcomes
Primary outcome [1] 295536 0
The total amount of IV insulin (units) titrated to maintain blood glcose levels at 5.0mmol/L after a high protein meal compared to a control meal.
Timepoint [1] 295536 0
5 hours post prandial
Secondary outcome [1] 315798 0
The change in serum assay levels of gastrointestinal hormones on consumption of high protein meal copared to control meal.
Timepoint [1] 315798 0
15- 60 minute intervals for 5 hours post prandial
Secondary outcome [2] 315799 0
The number of Hypoglycaemic events (defined as plasma glucose levels less than 3.5mmol/L)
Timepoint [2] 315799 0
During the 5 hour period following the meal consumpion

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
Actual
30/01/2015
Date of last participant enrolment
Anticipated
Actual
7/01/2016
Date of last data collection
Anticipated
Actual
28/01/2016
Sample size
Target
15
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 4036 0
Princess Margaret Hospital - Subiaco
Recruitment hospital [2] 4037 0
John Hunter Children's Hospital - New Lambton
Recruitment postcode(s) [1] 9952 0
6008 - Subiaco
Recruitment postcode(s) [2] 9953 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 291635 0
Charities/Societies/Foundations
Name [1] 291635 0
Diabetes Australia
Country [1] 291635 0
Australia
Funding source category [2] 291636 0
Charities/Societies/Foundations
Name [2] 291636 0
Princess Margaret Hospital Foundation
Country [2] 291636 0
Australia
Funding source category [3] 291638 0
Commercial sector/Industry
Name [3] 291638 0
Novo Nordisk Regional diabetes support scheme
Country [3] 291638 0
Australia
Primary sponsor type
Hospital
Name
Princess Margaret Hospital
Address
Roberts Rd, Subiaco WA 6008
Country
Australia
Secondary sponsor category [1] 290308 0
Hospital
Name [1] 290308 0
John Hunter Children's Hospital
Address [1] 290308 0
Lookout Road, New Lambton NSW 2305
Country [1] 290308 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293166 0
Princess Margaret Hospital Human Research Ethics Committee
Ethics committee address [1] 293166 0
Ethics committee country [1] 293166 0
Australia
Date submitted for ethics approval [1] 293166 0
Approval date [1] 293166 0
10/12/2014
Ethics approval number [1] 293166 0
2014104EP
Ethics committee name [2] 293167 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 293167 0
Ethics committee country [2] 293167 0
Australia
Date submitted for ethics approval [2] 293167 0
Approval date [2] 293167 0
26/06/2015
Ethics approval number [2] 293167 0
H-2015-0227

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 522 522 0 0
/AnzctrAttachments/368920-ethics approval.pdf
Attachments [2] 523 523 0 0
/AnzctrAttachments/368920-JHCH ethics approval.pdf

Contacts
Principal investigator
Name 58738 0
Prof Elizabeth Davis
Address 58738 0
Princess Margaret Hospital
Diabetes and Endocrinology Department
GPO Box D184
perth
WA
6840
Country 58738 0
Australia
Phone 58738 0
+61 0864561111
Fax 58738 0
Email 58738 0
[email protected]
Contact person for public queries
Name 58739 0
Elizabeth Davis
Address 58739 0
Princess Margaret Hospital
Diabetes and Endocrinology Department
GPO Box D184
Perth
WA
6840
Country 58739 0
Australia
Phone 58739 0
+61 0834561111
Fax 58739 0
Email 58739 0
[email protected]
Contact person for scientific queries
Name 58740 0
Elizabeth Davis
Address 58740 0
Princess Margaret Hospital
Diabetes and Endocrinology Department
GPO Box D184
Perth
WA
6840
Country 58740 0
Australia
Phone 58740 0
+61 0864561111
Fax 58740 0
Email 58740 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.