Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000246785
Ethics application status
Approved
Date submitted
21/01/2022
Date registered
10/02/2022
Date last updated
17/11/2022
Date data sharing statement initially provided
10/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Does the distribution of carbohydrates in meals effect blood sugar responses for adults with Type 2 Diabetes following a low carbohydrate diet?
Scientific title
Effects of the distribution of carbohydrates in meals on blood glucose responses in adults with Type 2 Diabetes on a low carbohydrate diet
Secondary ID [1] 306251 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 324981 0
Condition category
Condition code
Metabolic and Endocrine 322420 322420 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This randomised cross over control trial compares 3 three intervention arms and a habitual control. All interventions are 3-days with a 4-day washout period. Participants will wear an activity monitor continuously during the 3-day interventions and a continuous glucose monitor (CGM) for the entire 4 week intervention period. Participants will record daily intake daily using a weighed food record during the 4 week period.

LC15:
Participants will consume a diet of 90g carbohydrate distributed in 15g doses across 6 meals.

LC30:
Participants will consume a diet of 90g carbohydrate distributed in 30g doses across 3 meals, with the other 3 meals as close to 0g carbohydrate as possible.

LC90:
Participants will consume a diet of 90g carbohydrate distributed in any pattern they choose across 6 meals.

For all intervention days food items will remain constant, with only the distribution of the food items as a variable.

Participants will be provided with daily meal plans tailored to their intake needs using the Mifflin equation along with the raw ingredients required to construct the simple meals and snacks. No outside meals or snacks will be consumed during each 3-day duration, however water and unsweetened black coffee/tea etc (non caloric beverages) can be consumed as desired.


For LC15 and LC30 participants will consume 3 meals and 3 snacks as prescribed in their meal plan. The timing of the meals will be at the participants discretion but matched between conditions and recorded as part of the weighed food record. For LC90, participants will eat the same foods as during LC15 and LC30, however these foods may be consumed in any pattern and prepared as desired.
Intervention code [1] 322656 0
Lifestyle
Comparator / control treatment
Habitual control:
Participants will continue on their usual diet for 3 days at the start of the trial while wearing an activity monitor, CGM and recording daily intake using a weighed food record, as they will during the 3 intervention arms.
Control group
Active

Outcomes
Primary outcome [1] 330183 0
24 h incremental area under the glucose curve, measured using a continuous glucose monitor (CGM).
Timepoint [1] 330183 0
During each 3 day intervention period
Secondary outcome [1] 405163 0
Fasting blood glucose measured via CGM
Timepoint [1] 405163 0
Continuously during each 3 day intervention periods and control
Secondary outcome [2] 405164 0
Mean 24-h glucose measured via CGM
Timepoint [2] 405164 0
continuously during each 3 day intervention periods and control
Secondary outcome [3] 405165 0
Time in range (4-10 mmol/L) measured via CGM
Timepoint [3] 405165 0
continuously during each 3 day intervention periods and control
Secondary outcome [4] 405166 0
Time > 10.0 mmol/L measured via CGM
Timepoint [4] 405166 0
continuously during each 3 day intervention periods and control
Secondary outcome [5] 405167 0
glycaemic variability (including SD, MAG) measured via easy GV software
Timepoint [5] 405167 0
continuously during each of the 3 day intervention periods and control
Secondary outcome [6] 405170 0
adherence to interventions from food pictures and weighed food record
Timepoint [6] 405170 0
Daily for the 4 week study duration
Secondary outcome [7] 405228 0
Physical activity and sedentary time measured from activity monitor
Timepoint [7] 405228 0
continuously during 3-day interventions and control
Secondary outcome [8] 405229 0
nocturnal/overnight glucose measured via CGM
Timepoint [8] 405229 0
continuously during 3-day interventions and control
Secondary outcome [9] 405230 0
postprandial glucose measured from the 2-h post-meal via CGM
Timepoint [9] 405230 0
continuously during 3-day interventions and control

Eligibility
Key inclusion criteria
Aged between 18 and 80 years
Formal diagnosis of type 2 diabetes
Stable medication for previous 3 months
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-English speakers
High risk kidney or liver diseases
Insulin or sulfonylureas
Pregnancy and breastfeeding

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)
randomisation using sealed envelop computer program
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation
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
linear mixed model

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2023
Actual
Date of last participant enrolment
Anticipated
1/07/2024
Actual
Date of last data collection
Anticipated
30/08/2024
Actual
Sample size
Target
19
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310597 0
University
Name [1] 310597 0
University of Wollongong
Country [1] 310597 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Northfields Avenue Wollongong NSW 2500
Country
Australia
Secondary sponsor category [1] 311789 0
None
Name [1] 311789 0
Address [1] 311789 0
Country [1] 311789 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310201 0
University of Wollongong The Health & Medical HREC
Ethics committee address [1] 310201 0
Ethics committee country [1] 310201 0
Australia
Date submitted for ethics approval [1] 310201 0
25/10/2021
Approval date [1] 310201 0
06/02/2022
Ethics approval number [1] 310201 0
2021/367

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

Contacts
Principal investigator
Name 116850 0
Dr Monique Francois
Address 116850 0
university of Wollongong, Northfields avenue, Wollongong, NSW 2500
Country 116850 0
Australia
Phone 116850 0
+61 2 4221 5136
Fax 116850 0
Email 116850 0
[email protected]
Contact person for public queries
Name 116851 0
Katie Oetsch
Address 116851 0
university of Wollongong, Northfields avenue, Wollongong, NSW 2500
Country 116851 0
Australia
Phone 116851 0
+61 2 4221 5136
Fax 116851 0
Email 116851 0
[email protected]
Contact person for scientific queries
Name 116852 0
Katie Oetsch
Address 116852 0
university of Wollongong, Northfields avenue, Wollongong, NSW 2500
Country 116852 0
Australia
Phone 116852 0
+61 2 4221 5136
Fax 116852 0
Email 116852 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14734Ethical approval  [email protected]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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