ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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Trial registered on ANZCTR

Registration number

ACTRN12616000861459

Ethics application status

Approved

Date submitted

1/06/2016

Date registered

30/06/2016

Date last updated

5/10/2024

Date data sharing statement initially provided

20/10/2021

Date results provided

20/10/2021

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]

Nil known

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 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]

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]

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]

5 hours after the commencement of the test meal

Secondary outcome [1]

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

Timepoint [1]

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

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

6/07/2016

Actual

25/07/2016

Date of last participant enrolment

Anticipated

31/12/2016

Actual

3/07/2017

Date of last data collection

Anticipated

Actual

17/07/2017

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]

Juvenile Diabetes Research Fund

Address [1]

Perth
Unit 3
181 Main Street
Osborne Park WA 6017

Country [1]

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]

01/04/2016

Approval date [1]

21/04/2016

Ethics approval number [1]

2016049EP

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]

20/04/2016

Approval date [2]

08/06/2016

Ethics approval number [2]

16/05/18/4.02

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

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

+61864561111

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

+61864561111

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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