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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] 281994 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes mellitus 288442 0
Condition category
Condition code
Metabolic and Endocrine 288790 288790 0 0
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] 286576 0
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] 288930 0
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] 288930 0
8 hours after the test meal is consumed
Secondary outcome [1] 301377 0
The rate of maximal BGL increase every hour up to 8 hours post prandial.
Timepoint [1] 301377 0
8 hours after the test meal is consumed
Secondary outcome [2] 301378 0
The time it takes for the BGL to reach maximum excursion as measured by the CGM
Timepoint [2] 301378 0
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?
No
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
31
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 286786 0
Commercial sector/Industry
Name [1] 286786 0
Novo Nordisk Pharmaceuticals
Country [1] 286786 0
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] 285569 0
None
Name [1] 285569 0
Address [1] 285569 0
Country [1] 285569 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288848 0
John Hunter Hospital
Ethics committee address [1] 288848 0
Lookout Rd
New Lambton
NSW 2310
Ethics committee country [1] 288848 0
Australia
Date submitted for ethics approval [1] 288848 0
28/02/2013
Approval date [1] 288848 0
Ethics approval number [1] 288848 0

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 38018 0
A/Prof Bruce King
Address 38018 0
John Hunter Children's Hospital
Department of Diabetes and Endocrinology
Lookout Rd
New Lambton
NSW 2310
Country 38018 0
Australia
Phone 38018 0
+61 024249855634
Fax 38018 0
Email 38018 0
Bruce. [email protected]
Contact person for public queries
Name 38019 0
Bruce King
Address 38019 0
John Hunter Children's Hospital
Department of Diabetes and Endocrinology
Lookout Rd
New Lambton
NSW 2310
Country 38019 0
Australia
Phone 38019 0
+61 024249855634
Fax 38019 0
Email 38019 0
[email protected]
Contact person for scientific queries
Name 38020 0
Bruce King
Address 38020 0
John Hunter Children's Hospital
Department of Diabetes and Endocrinology
Lookout Rd
New Lambton
NSW 2310
Country 38020 0
Australia
Phone 38020 0
+61 024249855634
Fax 38020 0
Email 38020 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

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