ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12613000215729

Ethics application status

Not yet submitted

Date submitted

22/02/2013

Date registered

25/02/2013

Date last updated

25/02/2013

Type of registration

Prospectively registered

Titles & IDs

Public title

How does the protein content in meals influence post prandial bood glucose levels in individuals with type 1 diabetes mellitus?

Scientific title

For people with type 1 diabetes mellitus, does the post prandial blood glucose level significantly alter following a meal containing protein versus a meal without protein?

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 mellitus

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Intervention/exposure

Study type

Observational

Patient registry

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

The study duration will be 5 days. On day one, the participant will be connected to a continuous blood glucose monitor sensor (CGMS), which will remain in place for the 5 day duration of the study. The CGM sensor is a small plastic catheter inserted just beneath the skin. For 5 consecutive days the participant will be instructed to eat a standard evening meal with consistent amounts and type of carbohydrate. Usual insulin doses will be given prior to the meal for the carbohydrate content. This will be followed by a test meal (a protein drink) to be consumed 4 hours later. The participant will then fast overnight. The blood glucose level (BGL) will be observed via the CGM every hour for an 8 hour period (overnight). The participant will then test their BGL each morning of the study prior to breakfast with a fingerprick blood test, as per usual diabetes management for individuals with type 1 diabetes mellitus.

Intervention code [1]

Not applicable

Comparator / control treatment

The participants postprandial blood glucose level will be compared 8 hours following a meal containing protein with the postparandial BGL following a non protein meal.
The first day of the study period the participant will not cosume a protein meal. Each day for the following 4 days they will be given a test meal containing various amounts of protein.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

The primary outcome will be measured using the data from the CGM trace.
The primary outcome will be the glucose excursion at 8 hours after the test meal of protein.

Timepoint [1]

8 hours after the test meal is consumed

Secondary outcome [1]

The rate of maximal BGL increase every hour up to 8 hours post prandial.

Timepoint [1]

8 hours after the test meal is consumed

Secondary outcome [2]

The time it takes for the BGL to reach maximum excursion as measured by the CGM

Timepoint [2]

Up to 8 hours following the test meal

Eligibility

Key inclusion criteria

Type 1 diabetes mellitus

HbA1c <8.5%
BMI < 91st centile
No other medical conditions
Diabetes for > 6 months
Using multiple daily injections or insulin pump therapy

Minimum age

7 Years

Maximum age

40 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

HbA1c >8.5%
BMI > 91st centile
Other co-exisiting medical conditions
Complications of diabetes
Onset of diabetes <6 months

Study design

Purpose

Duration

Selection

Timing

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

3/06/2013

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

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Novo Nordisk Pharmaceuticals

Address [1]

Level 3, 21 Solent Circuit
Baulkham Hills
NSW 2153

Country [1]

Australia

Primary sponsor type

Commercial sector/Industry

Name

Novo Nordisk pharmaceuticals

Address

Level 3, 21 Solent Circuit
Baulkham Hills
NSW 2153

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

John Hunter Hospital

Ethics committee address [1]

Lookout Rd
New Lambton
NSW 2310

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/02/2013

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

To properly manage type 1 diabetes, individuals are required to measure blood glucose levels (BGL's)regularly and adjust the amount of insulin to be given accordingly. This has been done by matching the amount of insulin with the amount of carbohydrate in a meal.
Recent studies have shown that meals high in protein can also significantly increase the BGL. There are recommendations that additional insulin be given with meals containing high levels of protein to prevent post prandial hypergycaemia (elevated BGL's after a  meal).
However, at this time there is insufficient data to determine how these additional insulin doses should be calculated. A current algorithm used to calculate additional insulin based on protein content in a meal has been shown to cause unacceptable levels of hypoglycaemia.
We will recruit 31 people with type 1 diabetes between the ages of 7 and 40 years diagnosed for more than 1 year, using either insulin pump therapy or multiple daily injection therapy. Participants will have a glycated haemaglobin of <8.5% and body mass index <91st centile. Exclusion criteria will be those with co-existing medical conditions.
The aim of this study will be to:
 Define the impact of variable protein loads on post prandial BGL's up to 8 hours. 
 
The participants will be contacted daily for the first week to monitor BGL's and adjust insulin doses. A continuous glucose monitoring system (CGMS) which provides continuous measurement of BGL's will be inserted on the first day. For 5 consecutive days participants will be instructed to eat a standardised evening meal containing consistent quantities and type of carbohydrate. The participant will give a standard insulin bolus for the carbohydrate in the meal. They will then be instructed to eat a test meal (protein shake) 4 hours after the evening meal.
The participant will fast over night and check the BGL in the morning prior to eating breakfast. If the participant has has a BGL <3.5 mmols/L or has symptoms of hypoglycaemia at any time they will eat 15 grams of carbohydrate as per their usual management.
During the test meal study days exercise and evening food will be standardised.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Bruce King

Address

John Hunter Children's Hospital
Department of Diabetes and Endocrinology
Lookout Rd
New Lambton
NSW 2310

Country

Australia

Phone

+61 024249855634

Fax

Bruce. King@hnehealth.nsw.gov.au

Contact person for public queries

Name

Bruce King

Address

John Hunter Children's Hospital
Department of Diabetes and Endocrinology
Lookout Rd
New Lambton
NSW 2310

Country

Australia

Phone

+61 024249855634

Fax

Bruce.King@hnehealth.nsw.gov.au

Contact person for scientific queries

Name

Bruce King

Address

John Hunter Children's Hospital
Department of Diabetes and Endocrinology
Lookout Rd
New Lambton
NSW 2310

Country

Australia

Phone

+61 024249855634

Fax

Bruce.King@hnehealth.nsw.gov.au

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.

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