ANZCTR - Registration

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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]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Type 2 Diabetes

Condition category

Condition code

Metabolic and Endocrine

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]

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]

24 h incremental area under the glucose curve, measured using a continuous glucose monitor (CGM).

Timepoint [1]

During each 3 day intervention period

Secondary outcome [1]

Fasting blood glucose measured via CGM

Timepoint [1]

Continuously during each 3 day intervention periods and control

Secondary outcome [2]

Mean 24-h glucose measured via CGM

Timepoint [2]

continuously during each 3 day intervention periods and control

Secondary outcome [3]

Time in range (4-10 mmol/L) measured via CGM

Timepoint [3]

continuously during each 3 day intervention periods and control

Secondary outcome [4]

Time > 10.0 mmol/L measured via CGM

Timepoint [4]

continuously during each 3 day intervention periods and control

Secondary outcome [5]

glycaemic variability (including SD, MAG) measured via easy GV software

Timepoint [5]

continuously during each of the 3 day intervention periods and control

Secondary outcome [6]

adherence to interventions from food pictures and weighed food record

Timepoint [6]

Daily for the 4 week study duration

Secondary outcome [7]

Physical activity and sedentary time measured from activity monitor

Timepoint [7]

continuously during 3-day interventions and control

Secondary outcome [8]

nocturnal/overnight glucose measured via CGM

Timepoint [8]

continuously during 3-day interventions and control

Secondary outcome [9]

postprandial glucose measured from the 2-h post-meal via CGM

Timepoint [9]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Wollongong

Address [1]

Northfields Avenue Wollongong NSW 2500

Country [1]

Australia

Primary sponsor type

University

Name

University of Wollongong

Address

Northfields Avenue Wollongong NSW 2500

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Wollongong The Health & Medical HREC

Ethics committee address [1]

Northfields Avenue Wollongong NSW 2500

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/10/2021

Approval date [1]

06/02/2022

Ethics approval number [1]

2021/367

Summary

Brief summary

People with type 2 diabetes have high blood glucose levels largely due to reduced action or section of the main hormone insulin. Larger spikes in glucose levels typically occur following the consumption of carbohydrates. Lowering carbohydrate intake is one way to improve glucose levels. However, it unknown if the distribution of carbohydrate at each meal and snack also influences daily blood glucose averages; specifically in the context of a lower carbohydrate diet. 

The main objective of this study is to determine if consuming a moderately low-carbohydrate diet of 90g across different distribution patterns will have an impact on blood glucose management. The primary outcome is the change in blood glucose with continuous glucose monitoring over each of the three 3-day periods following different carbohydrate distribution patterns.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Monique Francois

Address

university of Wollongong, Northfields avenue, Wollongong, NSW 2500

Country

Australia

Phone

+61 2 4221 5136

Fax

francois@uow.edu.au

Contact person for public queries

Name

Katie Oetsch

Address

university of Wollongong, Northfields avenue, Wollongong, NSW 2500

Country

Australia

Phone

+61 2 4221 5136

Fax

kmo353@uowmail.edu.au

Contact person for scientific queries

Name

Katie Oetsch

Address

university of Wollongong, Northfields avenue, Wollongong, NSW 2500

Country

Australia

Phone

+61 2 4221 5136

Fax

kmo353@uowmail.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
14734	Ethical approval			kmo353@uowmail.edu.au

Results publications and other study-related documents

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Documents added automatically

No additional documents have been identified.

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