Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000425695
Ethics application status
Approved
Date submitted
5/04/2023
Date registered
28/04/2023
Date last updated
27/10/2023
Date data sharing statement initially provided
28/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Low Glycaemic Load Breakfast for the management of Gestational Diabetes Mellitus - A randomised controlled, cross-over, pilot clinical trial
Scientific title
Low Glycaemic Load Breakfast versus a Traditional High Glycaemic Load Breakfast for the management of Postprandial Blood Glucose Response and 24 hour Glycaemic Variability in Women diagnosed with Gestational Diabetes - A randomised controlled, cross-over pilot clinical trial
Secondary ID [1] 309193 0
None
Universal Trial Number (UTN)
U1111-1289-6753
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational Diabetes 329336 0
Condition category
Condition code
Metabolic and Endocrine 326278 326278 0 0
Diabetes
Reproductive Health and Childbirth 326279 326279 0 0
Antenatal care
Diet and Nutrition 326516 326516 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Breakfast Intervention: Low glycaemic load (LGL) breakfast consisting of a nut and seed granola with almond milk. The breakfast is to be consumed at a consistent time between 6:00am and 9:00am for seven consecutive mornings. A seven day food and exercise diary will be used to check adherence.

Post breakfast consumption, participants will be asked to follow current practice gestational diabetes mellitus diet prescription which consists of a moderate carbohydrate diet spread evenly across the day. Participants will also be advised on physical activity guidelines (RANZCOG). They should aim to achieve at least 30 minutes per day, five days per week of moderate intensity physical activity such as a brisk walk.

There is also a 7 day wash out period between treatments where participants follow the current diet prescription and the physical activity guidelines.
Intervention code [1] 325638 0
Lifestyle
Comparator / control treatment
Breakfast control: Traditional, high glycaemic load (HGL) breakfast consisting of cereal, cows milk and fruit. The breakfast is to be consumed at a consistent time between 6:00am and 9:00am for seven consecutive mornings. A seven day food and exercise diary will be used to check adherence.

Post breakfast consumption, participants will be asked to follow current practice gestational diabetes mellitus diet prescription which consists of a moderate carbohydrate diet spread evenly across the day. Participants will also be advised on physical activity guidelines (RANZCOG). They should aim to achieve at least 30 minutes per day, five days per week of moderate intensity physical activity such as a brisk walk.
Control group
Active

Outcomes
Primary outcome [1] 334146 0
The primary outcome will be glycaemic variability assessed as Time in Range (%). Data from continuous glucose monitors will be used to assess this outcome.
Timepoint [1] 334146 0
This will be measured continuously during the 7 day intervention and control periods.
Primary outcome [2] 336413 0
The second primary outcome will be post-prandial (breakfast) glucose level (mean +/-SD)
Timepoint [2] 336413 0
Primary outcome [3] 336414 0
The second primary outcome will be post-prandial (breakfast) glucose level (mean +/-SD)
Timepoint [3] 336414 0
This daily post breakfast glucose will be obtained through continuous glucose monitoring data during the 7 day intervention and control periods.
Secondary outcome [1] 419475 0
The first secondary outcome will be measuring glycaemic variability assessed as Time Above Range (%). Data from continuous glucose monitors will be used to assess this outcome.
Timepoint [1] 419475 0
This will be measured continuously during the 7 day intervention and control periods.
Secondary outcome [2] 420879 0
The second secondary outcome will be measuring glycaemic variability assessed as Time Below Range (%). Data from continuous glucose monitors will be used to assess this outcome.
Timepoint [2] 420879 0
This will be measured continuously during the 7 day intervention and control periods.
Secondary outcome [3] 420880 0
Safety measure - fasting lipids.
Timepoint [3] 420880 0
These fasting blood samples will be drawn in the morning at the commencement and end of each treatment intervention and control period.
Secondary outcome [4] 420881 0
Safety measure - beta-hydroxybutyrate.
Timepoint [4] 420881 0
These fasting blood samples will be drawn in the morning at the commencement and end of each treatment intervention and control period.

Eligibility
Key inclusion criteria
* BMI:>18 kg/m2
* Diagnosed with gestational diabetes mellitus prior to 28 weeks’ gestation, based on the Australasian Diabetes in Pregnancy Society (ADIPS) criteria (fasting glucose more than or equal to 5.1 mmol/L, 1-h glucose more than or equal to 10.0 mmol/L and/or 2-h glucose more than or equal to 8.5 mmol/L following a 2-h 75g oral glucose tolerance test),
* Singleton pregnancy
* Intending to deliver at Royal Prince Alfred Hospital Women and Babies
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Multiple pregnancy
* Physical or psychological conditions that contraindicate participation including history of an eating disorder
* Overt hypertriglyceridaemia (triglycerides > 5 mmol/L)
* Current metformin or insulin therapy
* Smoking
* Current breastfeeding
* Special dietary requirements (e.g. coeliac disease, veganism); nut allergy or lactose intolerance
* Pre-existing diabetes or diabetes mellitus in pregnancy
* Gestational diabetes mellitus diagnosed after 28 weeks’ gestation defined by ADIPS criteria.

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)
Treatment allocation will use block computer generated randomisation with a 1:1 allocation ratio to the low glycaemic load breakfast or usual care (high glycaemic load breakfast) for the initial 7-days. The randomisation will be centralised by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be stratified according to BMI (< or >/=25 kg/m2); ethnicity (Caucasian, South-East Asian and South Asian) and timing of GDM diagnosis (<24 weeks’ gestation vs >24 weeks’ gestation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Paired t-tests will be used to compare differences between the treatment interventions. Additionally, mixed effects longitudinal models with treatments (random effects) and time (meal occasion: breakfast, lunch and dinner) will be used to examine the post prandial glucose responses to each meal occasion between treatments. Bonferroni correction will be made to determine differences between diets at a specific meal occasion. Correlation and multiple regression analyses will be used to determine relationships between variables. Statistical tests will be performed with a level =0.05 (2-tailed).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/10/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24278 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 39820 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 313387 0
Other Collaborative groups
Name [1] 313387 0
Sydney Local Health District Institute for Women, Children and their Families
Country [1] 313387 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Royal Prince Alfred Hospital Diabetes Centre
Royal Prince Alfred Hospital
Level 6, 50 Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 315152 0
None
Name [1] 315152 0
Address [1] 315152 0
Country [1] 315152 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312604 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 312604 0
Ethics committee country [1] 312604 0
Australia
Date submitted for ethics approval [1] 312604 0
28/08/2022
Approval date [1] 312604 0
27/10/2022
Ethics approval number [1] 312604 0
2022/ETH01515

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

Contacts
Principal investigator
Name 125258 0
Dr Arianne Sweeting
Address 125258 0
Endocrinology & Metabolism Unit
Level 6 West
Royal Prince Alfred Hospital
Missenden Road Camperdown NSW 2050
Country 125258 0
Australia
Phone 125258 0
+61413784585
Fax 125258 0
Email 125258 0
[email protected]
Contact person for public queries
Name 125259 0
Arianne Sweeting
Address 125259 0
Endocrinology & Metabolism Unit
Level 6 West
Royal Prince Alfred Hospital
Missenden Road Camperdown NSW 2050
Country 125259 0
Australia
Phone 125259 0
+61413784585
Fax 125259 0
Email 125259 0
[email protected]
Contact person for scientific queries
Name 125260 0
Arianne Sweeting
Address 125260 0
Endocrinology & Metabolism Unit
Level 6 West
Royal Prince Alfred Hospital
Missenden Road Camperdown NSW 2050
Country 125260 0
Australia
Phone 125260 0
+61413784585
Fax 125260 0
Email 125260 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
This is a pilot study, assessing the feasibility of the intervention to inform a larger trial.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18783Ethical approval  [email protected] Please contact Research Ethics and Governance Offi... [More Details]



Results publications and other study-related documents

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