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Trial registered on ANZCTR


Registration number
ACTRN12614001150639
Ethics application status
Approved
Date submitted
15/10/2014
Date registered
30/10/2014
Date last updated
18/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Understanding the utilisation of protein in a restricted carbohydrate environment in Type 1 diabetes
Scientific title
Understanding the utilisation of dietary protein in type 1 diabetes patients on a restricted carbohydrate diet - developing a tool for protein counting.
Secondary ID [1] 285499 0
None
Universal Trial Number (UTN)
none
Trial acronym
none
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 293287 0
Condition category
Condition code
Metabolic and Endocrine 293556 293556 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The hypothesis: once habituated to a low carbohydrate diet (75g carbohydrate per day for 4 weeks), an insulin bolus for protein intake is required to maintain glycaemic control, due to gluconeogenesis from protein. The starting point for this bolus is that it will be twice the carbohydrate to insulin ratio. For example, if a patient uses a ratio of 1 unit insulin to 10g carbohydrate, they will use 1 unit to 20g protein. To test this each participant (habituated to a low carbohydrate diet) will undergo 6 meal tests/. The intervention meal tests are meal tests 4-6 (identical): 40g protein + 8g carbs from a protein shake and giving a bolus for carbohydrate and protein. Participants will have baseline glucose checked before starting the meal test, if blood glucose is outside of 4-8mmol then test will be postponed. Meal and insulin bolus will be administered at time 0, blood will be taken at 10, 20, 30, 60, 90, 120, 150, 180 mins. Washout period between meal tests will be 48 hrs.
Intervention code [1] 290437 0
Lifestyle
Comparator / control treatment
The comparator meal tests are meal tests 1-3 (identical): 40g protein + 8g carbs from a protein shake and giving an insulin bolus for carbohydrate only, as bolusing for carbohydrate is the standard treatment.
Control group
Active

Outcomes
Primary outcome [1] 293373 0
Area under the curve for glucose. Glucose is assessed by serum assay.
Timepoint [1] 293373 0
Serum Glucose taken at baseline (time 0), 10, 20, 30, 60, 90, 120, 150, 180 mins post administration of meal and insulin bolus.
Secondary outcome [1] 310886 0
Glucose excursion above 8mmol/L. Glucose is assessed by serum assay, and also blood glucometer.
Timepoint [1] 310886 0
Serum Glucose taken at baseline (time 0), 10, 20, 30, 60, 90, 120, 150, 180 mins post administration of meal and insulin bolus. Blood glucometer taken at time 0, 60, 120 and 180 mins post administration of meal and insulin bolus.

Eligibility
Key inclusion criteria
Type 1 diabetes mellitus on a basal/bolus insulin regimen
Good understanding of carbohydrate counting and insulin ratios
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant or breastfeeding women
Unstable glycaemic control – HbA1c greater than or equal to
85
Renal failure - eGFR greater than or equal to 30mls/min or urinary macroalbumin:creatinine greater than or equal to 30
Use of an insulin pump

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)
All participants will undertake all meal tests, but in random order. allocation will be concealed by opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random order will be computer generated using random.org
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/04/2016
Actual
5/09/2016
Date of last participant enrolment
Anticipated
Actual
2/08/2017
Date of last data collection
Anticipated
Actual
13/09/2017
Sample size
Target
16
Accrual to date
Final
16
Recruitment outside Australia
Country [1] 6423 0
New Zealand
State/province [1] 6423 0
Wellington

Funding & Sponsors
Funding source category [1] 290098 0
Charities/Societies/Foundations
Name [1] 290098 0
Cranfylde Trust
Country [1] 290098 0
New Zealand
Primary sponsor type
Government body
Name
Capital and Coast District Health Board
Address
Riddiford St,
Newtown
Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 288804 0
None
Name [1] 288804 0
None
Address [1] 288804 0
Country [1] 288804 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291806 0
Health and Disability Ethics Committee
Ethics committee address [1] 291806 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6021
Ethics committee country [1] 291806 0
New Zealand
Date submitted for ethics approval [1] 291806 0
12/11/2014
Approval date [1] 291806 0
07/01/2015
Ethics approval number [1] 291806 0

Summary
Brief summary
This exploratory study aims to understand the relationship between protein and insulin requirements in differing carbohydrate environments in participants with type 1 diabetes. The hypothesis: once habituated to a low carbohydrate diet, an insulin bolus for protein intake is required to maintain glycaemic control, due to gluconeogenesis from protein. The starting point for this bolus is that it will be twice the carbohydrate to insulin ratio. For example, if a patient uses a ratio of 1 unit insulin to 10g carbohydrate, they will use 1 unit to 20g protein.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52102 0
Dr Amber Parry Strong
Address 52102 0
Wellington Hospital
Riddiford St
Wellington 6021
Country 52102 0
New Zealand
Phone 52102 0
+64 4 8062458
Fax 52102 0
Email 52102 0
[email protected]
Contact person for public queries
Name 52103 0
Amber Parry Strong
Address 52103 0
Wellington Hospital
Riddiford St
Wellington 6021
Country 52103 0
New Zealand
Phone 52103 0
+64 4 8062458
Fax 52103 0
Email 52103 0
[email protected]
Contact person for scientific queries
Name 52104 0
Amber Parry Strong
Address 52104 0
Wellington Hospital
Riddiford St
Wellington 6021
Country 52104 0
New Zealand
Phone 52104 0
+64 4 8062458
Fax 52104 0
Email 52104 0
[email protected]

No information has been provided regarding IPD availability


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.