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 information initially 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
Roberts Road, Subiaco WA 6008
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
University Dr, Callaghan NSW 2308
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
Clinical experience and reports from families of children with type 1 diabetes has long suggested that meals high in protein and/or fat cause an increase in blood glucose levels after eating. Increased blood glucose levels, including after consumption of food, is well-known to add to long term health complications in type 1 diabetes. Current type 1 diabetes management guidelines recommend adjusting insulin doses for food based on the amount of carbohydrate to be eaten at each meal. However, there has been an increase in evidence, including that from a recent study by our study group, to suggest that other nutrients such as fat and protein should be considered when calculating pre meal insulin. High levels of protein and/or fat in a meal cause a larger than expected rise in blood glucose levels after eating and these high blood glucose levels persist, suggesting the need for extra insulin.

This research project will compare the insulin required to maintain blood glucose levels at a constant level when consuming two meals, one high in protein and the other low in protein. This will be determined by looking at the difference in intra venous insulin requirements after both meals. IV insulin will be given to participants to maintain blood glucose levels at a constant level whilst they are eating the meal and in the 5 hours following. Fifteen participants will consume both a high protein and a low protein meal, at least one week apart. The different insulin amounts needed to maintain blood glucose levels after each test meal will provide accurate calculation of the expected increase in insulin requirements on consumption of a high protein meal.

This study will provide important information in the management of type 1 diabetes in both adults and children. This information will be used immediately in our day to day management of patients and will guide the development of clinical guidelines to minimize the rise in blood glucose levels after eating.
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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes M. Evans C. E. M. Smart N. Paramalingam G. J. Smit... [More Details]

Documents added automatically
No additional documents have been identified.