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Trial registered on ANZCTR


Registration number
ACTRN12614000471684
Ethics application status
Not yet submitted
Date submitted
4/04/2014
Date registered
6/05/2014
Date last updated
6/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
How does dietary protein, when combined with carbohydrate, influence postprandial 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 and carbohydrate versus a meal with only carbohydrate?
Secondary ID [1] 284395 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes mellitus 291574 0
Condition category
Condition code
Metabolic and Endocrine 291954 291954 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants with type 1 diabetes using intensive insulin therapy will be recruited. There will be a lead in period of one week before commencement of the study. This will allow researchers to contact particpants on a daily basis to review blood glucose levels and make any necessary adjustments to insulin doses. This will ensure optimal glycaemic control for the study period. On the day prior to the study a continuous glucose monitor (CGM) will be inserted to measure interstitial glucose levels for the duration of the study (6 days). The CGM will be blinded for the duration of the study. Over a period of 6 days, participants will consume a standard evening meal of no more than 60 grams of carbohydrate and low fat, low protein. Participants will give an insulin bolus as per usual management.
Approximately 4 hours after each evening meal, participants will consume a test meal as supper, consisting of a protein drink (containing protein in amounts of 0g, 12.5g, 25g, 50g, given in randomised order) mixed with 30g of carbohydrate. There will be 2 evenings of glucose only drinks in amounts of 30g and 50g glucose for comparison. Particpants will have insulin as per usual management for the 30g of carbohydrate. No further food or drink will be given (other than water) overnight unless the participant has an episode of hypoglycaemia (blood glucose < 3.5 mmol/L or becomes symptomatic). Interstitial glucose levels will be measured for the next 8 hours following consumption of the test meal drink.
The study will cease after the sixth night and the CGM will be removed.
Participants will be contacted daily by phone to assess progress with the study and a food, activity and blood glucose diary will be kept by participants to ensure adherance to the protocol.
Intervention code [1] 289128 0
Other interventions
Comparator / control treatment
Particpants will have a control night where they consume a test meal of 30g of carbohydrate only. This will allow for comparison with the evenings where they consume test meals of 30g of carbohydrate with various amounts of protein. Test meals and the control meal will be given in randomised order.
Control group
Active

Outcomes
Primary outcome [1] 291855 0
The primary outcome is the mean glucose excursion from the consumption of the test meal, measured at 30 minute intervals, up to 300 minutes. Glucose will be meaured using continuous glucose monitoring (CGM) which measures interstitial glucose levels continually, sending updated readings to a small reciever every 5 minutes. At the end of the study period the reciever will be uploaded to a computer data base, allowing for analysis of the glucose measurements after each test meal.
Timepoint [1] 291855 0
The primary timepoint is 300 minutes, measured at 30 minute intervals from the time of consumption of the test meal.
Secondary outcome [1] 307674 0
Secondary outcome will be the velocity of the glucose rise following consumption of the test meal.
The glucose rise will be measured using CGM overnight following consumption of the test meal. At the end of the study the CGM receiver will be uploaded to a computer data base where the data can be analysed and a graph produced to display the mean velocity of the glucose rise.
Timepoint [1] 307674 0
measured at 30 minute intervals to 300 minutes

Eligibility
Key inclusion criteria
Type 1 diabetes for at least 12 months
HbA1c 8.0% or less
BMI < 97th centile
Using intensive insulin therapy (multiple daily injection therapy 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 greater than 8.0%
BMI greater than 97th centile
Presence of any complications of diabetes
Presence of any other major 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
Generalised mixed linear models will be used for data analysis. This is to account for the repeated measures on each subject. In previous studies carried out by our group, a sample size of 32 has provided 80% power at the 0.05 significance level, to detect a potential mean difference in blood glucose of 2.0 mmol/l. This sample size will also allow for 10% missing data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2014
Actual
Date of last participant enrolment
Anticipated
30/10/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2296 0
John Hunter Children's Hospital - New Lambton
Recruitment postcode(s) [1] 7972 0
2305 - New Lambton Heights

Funding & Sponsors
Funding source category [1] 289041 0
Commercial sector/Industry
Name [1] 289041 0
Novo Nordisk Pharmaceuticals
Country [1] 289041 0
Australia
Primary sponsor type
Hospital
Name
John Hunter Children's Hospital
Address
Lookout Rd
New Lambton Heights.
NSW 2305
Country
Australia
Secondary sponsor category [1] 287711 0
None
Name [1] 287711 0
Address [1] 287711 0
Country [1] 287711 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290838 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 290838 0
Research Ethics and Governance Unit
Hunter New England Local Health District
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 290838 0
Australia
Date submitted for ethics approval [1] 290838 0
30/04/2014
Approval date [1] 290838 0
Ethics approval number [1] 290838 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 32 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 <8.0% and body mass index <97th 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 6 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 containing 30g of carbohydrate) 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 47534 0
A/Prof Bruce King
Address 47534 0
John Hunter Children's Hospital
Lookout Rd
New Lambton
NSW 2305
Country 47534 0
Australia
Phone 47534 0
+61 2 49213000
Fax 47534 0
Email 47534 0
[email protected]
Contact person for public queries
Name 47535 0
Megan Paterson
Address 47535 0
John Hunter Children's Hospital
Lookout Rd
New Lambton
NSW 2305
Country 47535 0
Australia
Phone 47535 0
+61 2 49213000
Fax 47535 0
Email 47535 0
[email protected]
Contact person for scientific queries
Name 47536 0
Bruce King
Address 47536 0
John Hunter Children's Hospital
Lookout Rd
New Lambton
NSW 2305
Country 47536 0
Australia
Phone 47536 0
+61 2 49213000
Fax 47536 0
Email 47536 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
SourceTitleYear of PublicationDOI
EmbaseIncreasing the protein quantity in a meal results in dose-dependent effects on postprandial glucose levels in individuals with Type 1 diabetes mellitus.2017https://dx.doi.org/10.1111/dme.13347
N.B. These documents automatically identified may not have been verified by the study sponsor.