ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Type 1 Diabetes

Condition category

Condition code

Inflammatory and Immune System

Autoimmune diseases

Metabolic and Endocrine

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]

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]

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]

5 hours post prandial

Secondary outcome [1]

The change in serum assay levels of gastrointestinal hormones on consumption of high protein meal copared to control meal.

Timepoint [1]

15- 60 minute intervals for 5 hours post prandial

Secondary outcome [2]

The number of Hypoglycaemic events (defined as plasma glucose levels less than 3.5mmol/L)

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,WA

Recruitment hospital [1]

Princess Margaret Hospital - Subiaco

Recruitment hospital [2]

John Hunter Children's Hospital - New Lambton

Recruitment postcode(s) [1]

6008 - Subiaco

Recruitment postcode(s) [2]

2305 - New Lambton

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Diabetes Australia

Address [1]

17 Barry
Drive TURNER ACT 2612

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Princess Margaret Hospital Foundation

Address [2]

68 Hay St, Subiaco WA 6008

Country [2]

Australia

Funding source category [3]

Commercial sector/Industry

Name [3]

Novo Nordisk Regional diabetes support scheme

Address [3]

Baulkham Hills Business Centre NSW 2153

Country [3]

Australia

Primary sponsor type

Hospital

Name

Princess Margaret Hospital

Address

Roberts Rd, Subiaco WA 6008

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

John Hunter Children's Hospital

Address [1]

Lookout Road, New Lambton NSW 2305

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Princess Margaret Hospital Human Research Ethics Committee

Ethics committee address [1]

Roberts Road, Subiaco WA 6008

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

10/12/2014

Ethics approval number [1]

2014104EP

Ethics committee name [2]

The University of Newcastle Human Research Ethics Committee

Ethics committee address [2]

University Dr, Callaghan NSW 2308

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

26/06/2015

Ethics approval number [2]

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]

/AnzctrAttachments/368920-ethics approval.pdf

Attachments [2]

/AnzctrAttachments/368920-JHCH ethics approval.pdf

Contacts

Principal investigator

Name

Prof Elizabeth Davis

Address

Princess Margaret Hospital
Diabetes and Endocrinology Department
GPO Box D184
perth
WA
6840

Country

Australia

Phone

+61 0864561111

Fax

elizabeth.davis@health.wa.gov.au

Contact person for public queries

Name

Elizabeth Davis

Address

Princess Margaret Hospital
Diabetes and Endocrinology Department
GPO Box D184
Perth
WA
6840

Country

Australia

Phone

+61 0834561111

Fax

diabetes.research@health.wa.gov.au

Contact person for scientific queries

Name

Elizabeth Davis

Address

Princess Margaret Hospital
Diabetes and Endocrinology Department
GPO Box D184
Perth
WA
6840

Country

Australia

Phone

+61 0864561111

Fax

diabetes.research@health.wa.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

Trial Review

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