Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001096549p
Ethics application status
Submitted, not yet approved
Date submitted
1/08/2024
Date registered
12/09/2024
Date last updated
12/09/2024
Date data sharing statement initially provided
12/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the metabolic effects of whey protein ingestion prior to exercise in adults with type 1 diabetes.
Scientific title
Investigating the metabolic effects of whey protein ingestion prior to exercise in adults with type 1 diabetes.
Secondary ID [1] 312646 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 334612 0
Condition category
Condition code
Metabolic and Endocrine 331198 331198 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants will undertake a range of exercise sessions with varying pre-exercise conditions and different exercise durations. All exercise sessions will be moderate intensity (50% of their VO2 max) aerobic exercise sessions conducted on a cycle ergometer (exercise bike). At screening individuals will participate in a VO2 max session to discover the appropriate testing value.

For each of the conditions participants will either ingest a whey protein isolate drink (True Protein, Whey Protein Isolate 90) mixed with 200ml of water, measured to ensure a protein content 0.5g/kg of body weight, or a control drink containing just 200ml of water in random order. The whey protein or control drink will be consumed within a 5 minute timeframe and once completed the participant will commence exercise activity 30 minutes later. This will be done under supervision of one of the study investigators, whom will also supervise the exercise sessions.

There will be four exercise sessions, each to be completed twice by each participant, (one control and one whey protein). Session A will require a pre-exercise meal and insulin bolus to be administered 4 hours prior to exercise with a temporary target set on the automated insulin delivery (AID) device 2 hours pre-exercise. The exercise duration of this session will be 60 minutes. This session will be mandatory for all participants whom consent to be apart of the study to participate in. Sessions B, C and D will all be additional optional studies for participants to complete, however they must complete both protein and control sessions for each different exercise condition. Session B will require a pre-exercise meal and insulin bolus to be administered 2 hours prior to exercise with a temporary target set on the AID device 2 hours pre-exercise. The exercise duration of this session will be 60 minutes. Session C will require a pre-exercise meal and insulin bolus to be administered 4 hours prior to exercise with a temporary target set on the AID device 2 hours pre-exercise. The exercise duration of this session will be 90 minutes. Session D will be a rest session in which blood sample analysis will be completed. Individuals will consume a pre-exercise meal and insulin bolus will be administered 2 hours prior to the beginning of the rest session with a temporary target set on the AID device 2 hours before. Blood sampling will be done every 10 minutes from the time the whey protein or control drink is ingested for 120 minutes. Individuals who choose to complete this session will also receive blood sampling for comparison during their session A, every 10 minutes from when they ingest their control/whey protein drink to 30 minutes after their exercise session (total of 120 minutes). Session A represents 'optimal' pre-exercise and exercise duration conditions that match the recommendations. Sessions B and C represent 'sub-optimal' exercise conditions that are still in adherence with exercise guidelines, however these conditions generally confer greater risk of hypoglycaemia than session A. An individual will require a minimum of 48 hours between each exercise session.

The meal components will be specific to each participant based on their standard recommendation macronutrient and caloric intake, as determined by their clinician or diabetes educator. Their will be differences between the participants as their standardised meal will be based on individual factors such as; sex, age, average physical activity, etc. As long as the insulin bolus will be administered before the meal the duration of meal consumption does not need to be within a specific time frame rather should be as per standard eating habits. It will be ensured that on the days of these exercise studies that each individual is consistent with their pre-exercise meal caloric and macronutrient composition. Participants will administer their usual pre-lunch insulin bolus, based on their standard carbohydrate counting calculations.

If during the exercise sessions the sensor glucose levels drop below 7.0 mmol/L, 10g of carbohydrate will be consumed by the participant and a 15 minute break will be given to allow for a rise in blood glucose. This can be conducted up to three times during the exercise session (totalling 30g of carbohydrate) before the exercise session will be re-scheduled.
Intervention code [1] 329168 0
Treatment: Other
Comparator / control treatment
The control treatment will be a 250ml drink of water.
Control group
Active

Outcomes
Primary outcome [1] 338969 0
Total number of hypoglycaemic episodes for the 'optimal' condition (session A, B and D).
Timepoint [1] 338969 0
Exercise commencement (t = 0) to 2 hours post exercise (t = 180min).
Secondary outcome [1] 438064 0
Total number of hypoglycaemic episodes for the 'sub-optimal' condition (session C).
Timepoint [1] 438064 0
Exercise commencement (t = 0) to 2 hours post exercise (t = 210min).
Secondary outcome [2] 438073 0
Mean glucose on continuous glucose monitor (session A, B, D)
Timepoint [2] 438073 0
Drink ingestion (t = -30 min) to exercise commencement (t = 0).
Exercise commencement (t = 0) to 2 hours post exercise (t = 180min).
Exercise commencement (t = 0) to 6am the next day (t = 06:00am).
Secondary outcome [3] 438075 0
Mean glucose on continuous glucose monitor (session C)
Timepoint [3] 438075 0
Drink ingestion (t = -30 min) to exercise commencement (t = 0).
Exercise commencement (t = 0) to 2 hours post exercise (t = 210min).
Exercise commencement (t = 0) to 6am the next day (t = 06:00am).
Secondary outcome [4] 438077 0
Glycaemic variability on continuous glucose monitor (session A, B, D)
Timepoint [4] 438077 0
Drink ingestion (t = -30 min) to exercise commencement (t = 0).
Exercise commencement (t = 0) to 2 hours post exercise (t = 180min).
Exercise commencement (t = 0) to 6am the next day (t = 06:00am).
Secondary outcome [5] 438081 0
Glycaemic variability on continuous glucose monitor (session C)
Timepoint [5] 438081 0
Drink ingestion (t = -30 min) to exercise commencement (t = 0).
Exercise commencement (t = 0) to 2 hours post exercise (t = 210min).
Exercise commencement (t = 0) to 6am the next day (t = 06:00am).
Secondary outcome [6] 438083 0
Percentage time above range (>10.0 mmol/L) on continuous glucose monitor (session A, B, D)
Timepoint [6] 438083 0
Drink ingestion (t = -30 min) to exercise commencement (t = 0).
Exercise commencement (t = 0) to 2 hours post exercise (t = 180min).
Exercise commencement (t = 0) to 6am the next day (t = 06:00am).
Secondary outcome [7] 438085 0
Percentage time above range (>10.0 mmol/L) on continuous glucose monitor (session C)
Timepoint [7] 438085 0
Drink ingestion (t = -30 min) to exercise commencement (t = 0).
Exercise commencement (t = 0) to 2 hours post exercise (t = 210min).
Exercise commencement (t = 0) to 6am the next day (t = 06:00am).
Secondary outcome [8] 438087 0
Percentage time in range (3.9-10.0 mmol/L) on continuous glucose monitor (session A, B, D)
Timepoint [8] 438087 0
Drink ingestion (t = -30 min) to exercise commencement (t = 0).
Exercise commencement (t = 0) to 2 hours post exercise (t = 180min).
Exercise commencement (t = 0) to 6am the next day (t = 06:00am).
Secondary outcome [9] 438089 0
Percentage time in range (3.9-10.0 mmol/L) on continuous glucose monitor (session C)
Timepoint [9] 438089 0
Drink ingestion (t = -30 min) to exercise commencement (t = 0).
Exercise commencement (t = 0) to 2 hours post exercise (t = 210min).
Exercise commencement (t = 0) to 6am the next day (t = 06:00am).
Secondary outcome [10] 438091 0
Percentage time below range (3.0-3.8 mmol/L) on continuous glucose monitor (session A, B, D)
Timepoint [10] 438091 0
Drink ingestion (t = -30 min) to exercise commencement (t = 0).
Exercise commencement (t = 0) to 2 hours post exercise (t = 180min).
Exercise commencement (t = 0) to 6am the next day (t = 06:00am).
Secondary outcome [11] 438093 0
Percentage time below range (3.0-3.8 mmol/L) on continuous glucose monitor (session C)
Timepoint [11] 438093 0
Drink ingestion (t = -30 min) to exercise commencement (t = 0).
Exercise commencement (t = 0) to 2 hours post exercise (t = 210min).
Exercise commencement (t = 0) to 6am the next day (t = 06:00am).
Secondary outcome [12] 438095 0
Percentage time below range (<3.0 mmol/L) on continuous glucose monitor (session A, B, D)
Timepoint [12] 438095 0
Drink ingestion (t = -30 min) to exercise commencement (t = 0).
Exercise commencement (t = 0) to 2 hours post exercise (t = 180min).
Exercise commencement (t = 0) to 6am the next day (t = 06:00am).
Secondary outcome [13] 438097 0
Percentage time below range (<3.0 mmol/L) on continuous glucose monitor (session C)
Timepoint [13] 438097 0
Drink ingestion (t = -30 min) to exercise commencement (t = 0).
Exercise commencement (t = 0) to 2 hours post exercise (t = 210min).
Exercise commencement (t = 0) to 6am the next day (t = 06:00am).
Secondary outcome [14] 438099 0
Continuous glucose level at the time of exercise commencement (session A, B, C, D)
Timepoint [14] 438099 0
At exercise commencement (t = 0).
Secondary outcome [15] 438104 0
Number of sessions ended due to hypoglycaemia (session A, B, D)
Timepoint [15] 438104 0
Between exercise commencement (t = 0) and exercise completion (t = 60min)
Secondary outcome [16] 438107 0
Number of sessions ended due to hypoglycaemia (session C)
Timepoint [16] 438107 0
Between exercise commencement (t = 0) and exercise completion (t = 90min)
Secondary outcome [17] 438109 0
Total carbohydrate (g) consumed (session A, B, D)
Timepoint [17] 438109 0
From 10 minutes pre exercise commencement (t = -10 min) to 120-min post exercise (t = 180min)
Secondary outcome [18] 438113 0
Total carbohydrate (g) consumed (session C)
Timepoint [18] 438113 0
From 10 minutes pre exercise commencement (t = -10 min) to 120-min post exercise (t = 210min)
Secondary outcome [19] 438115 0
Total basal and bolus insulin delivered by the AID system (session A, B, D)
Timepoint [19] 438115 0
Drink ingestion (t = -30 min) to exercise commencement (t = 0).
Exercise commencement (t = 0) to 2 hours post exercise (t = 180min).
Exercise commencement (t = 0) to 6am the next day (t = 06:00am).
Secondary outcome [20] 438123 0
Total basal and bolus insulin delivered by the AID system (session A, B, D)
Timepoint [20] 438123 0
Drink ingestion (t = -30 min) to exercise commencement (t = 0).
Exercise commencement (t = 0) to 2 hours post exercise (t = 210min).
Exercise commencement (t = 0) to 6am the next day (t = 06:00am).
Secondary outcome [21] 438124 0
Plasma glucagon levels pre- during and post-exercise (session A)
Timepoint [21] 438124 0
From drink ingestion (t = -30) every 10 minutes until 30 minutes post-exercise (t = 90)
Secondary outcome [22] 438125 0
Plasma glucagon levels pre- during and post-rest session (session D)
Timepoint [22] 438125 0
From drink ingestion (t = -30) every 10 minutes until 30 minutes post-rest session (t = 90)

Eligibility
Key inclusion criteria
Age equal or greater than 18 years; type 1 diabetes of more than 1 year duration; C-peptide negative; HbA1c < 10.0% and ability to carbohydrate count.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy or planned pregnancy; is taking any medications that effect glucose metabolism; dietary restriction and/or other contraindication that prevents consumption of whey protein; uncontrolled coeliac disease; eGFR <40ml/min/1.73m2; history of diabetic ketoacidosis or severe hypoglycaemia in the prior 3 months; inability to complete exercise; and major medical or psychiatric illness.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No concealment is necessary for this trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation). Individuals will complete each of the four sessions twice. They will partake in sessions A to D in chronological order, however will in a randomised order either consume the whey protein or control drink first.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
1/06/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26882 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 42944 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 317066 0
Charities/Societies/Foundations
Name [1] 317066 0
Helmsley Charitable Trust
Country [1] 317066 0
United States of America
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
Country
Australia
Secondary sponsor category [1] 319315 0
None
Name [1] 319315 0
Address [1] 319315 0
Country [1] 319315 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315814 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [1] 315814 0
Ethics committee country [1] 315814 0
Australia
Date submitted for ethics approval [1] 315814 0
23/07/2024
Approval date [1] 315814 0
Ethics approval number [1] 315814 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135890 0
Dr Dale Morrison
Address 135890 0
University of Melbourne Dept of Medicine, St Vincent's Hospital Melbourne, 41 Victoria Pde Fitzroy VIC 3065
Country 135890 0
Australia
Phone 135890 0
+61413137853
Fax 135890 0
Email 135890 0
[email protected]
Contact person for public queries
Name 135891 0
Cara Schofield
Address 135891 0
University of Melbourne Dept of Medicine, St Vincent's Hospital Melbourne, 41 Victoria Pde Fitzroy VIC 3065
Country 135891 0
Australia
Phone 135891 0
+61412087513
Fax 135891 0
Email 135891 0
[email protected]
Contact person for scientific queries
Name 135892 0
Dale Morrison
Address 135892 0
University of Melbourne Dept of Medicine, St Vincent's Hospital Melbourne, 41 Victoria Pde Fitzroy VIC 3065
Country 135892 0
Australia
Phone 135892 0
+61413137853
Fax 135892 0
Email 135892 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All individual de-identified patient data will be available upon resonable written request.
When will data be available (start and end dates)?
Available no later then 12-months post close of clinical trial with no end date determined.
Available to whom?
De-identified data will be managed by a third-party platform. Researchers wishing to access data will need to provide a reasonable written request.
Available for what types of analyses?
Any reasonable relevant research.
How or where can data be obtained?
The funding body (Helmsley Charitable Trust) will designate a third party platform. The platform will require reasonable written request to access the data. Details of the data sharing platform are yet to be determined.

Written requests can be made to the principal investigator ([email protected]) for further information.


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.