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Trial registered on ANZCTR


Registration number
ACTRN12616000861459p
Ethics application status
Submitted, not yet approved
Date submitted
1/06/2016
Date registered
30/06/2016
Date last updated
30/06/2016
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
Gender
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
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Address [1] 293713 0
Perth
Unit 3
181 Main Street
Osborne Park WA 6017
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
Submitted, not yet approved
Ethics committee name [1] 295168 0
Princess Margaret Hospital Human Research Ethics Committee
Ethics committee address [1] 295168 0
Roberts Road, Subiaco WA 6008
Ethics committee country [1] 295168 0
Australia
Date submitted for ethics approval [1] 295168 0
01/04/2016
Approval date [1] 295168 0
Ethics approval number [1] 295168 0
Ethics committee name [2] 295169 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 295169 0
University Dr, Callaghan NSW 2308
Ethics committee country [2] 295169 0
Australia
Date submitted for ethics approval [2] 295169 0
20/04/2016
Approval date [2] 295169 0
Ethics approval number [2] 295169 0

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 lanmark 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 within target range when consuming two meals, one high in protein and fat and the other low in protein and fat, both with the same carbohydrate content. 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.

Thirteen participants will consume both test meals, 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/high fat 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

Contacts
Principal investigator
Name 66298 0
A/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
+63893408090
Fax 66298 0
Email 66298 0
elizabeth.davis@health.wa.gov.au
Contact person for public queries
Name 66299 0
Miss Megan Evans
Address 66299 0
Princess Margaret Hospital
Diabetes and Endocrinology Department
GPO Box D184
Perth
WA
6840
Country 66299 0
Australia
Phone 66299 0
+63893408090
Fax 66299 0
Email 66299 0
megan.evans@health.wa.gov.au
Contact person for scientific queries
Name 66300 0
Miss Megan Evans
Address 66300 0
Princess Margaret Hospital
Diabetes and Endocrinology Department
GPO Box D184
Perth
WA
6840
Country 66300 0
Australia
Phone 66300 0
+63893408090
Fax 66300 0
Email 66300 0
megan.evans@health.wa.gov.au

No information has been provided regarding IPD availability
Summary results
No Results