Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001676101
Ethics application status
Approved
Date submitted
13/11/2019
Date registered
29/11/2019
Date last updated
29/11/2019
Date data sharing statement initially provided
29/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The association between a modified carbohydrate diet, quality of life and glycaemic control in Australian adults with type 1 diabetes mellitus: A pilot study
Scientific title
The association between a modified carbohydrate diet, quality of life and glycaemic control in Australian adults with type 1 diabetes mellitus: A pilot study
Secondary ID [1] 299798 0
None
Universal Trial Number (UTN)
U1111-1243-5242
Trial acronym
Not applicable
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes Mellitus 315188 0
Condition category
Condition code
Metabolic and Endocrine 313503 313503 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group:
Pre-study procedure:
Participants will commence the study in a “rolling- start” manner rather than as a cohort of 23 to assist the management of participants. This will be the same for both intervention and matched controls group. For the intervention group, one week prior to the commencement of the intervention, participants who have never used a continuous glucose monitor (CGM) will be taught how to insert and use the CGM. Participants will also be reminder how to treat a hypoglycaemia to ensure correct management during the intervention in case this occurs.

Study procedure: Intervention group:
On the participants’ first day of the intervention, the participant’s weight and height will be recorded. Participants will complete the online participant information and consent form (PICF) and Australian Diabetes Specific Quality of Life Questionnaire at baseline. Weight will be recorded at the end of the study and the questionnaire will be re-administered at the end of week 13. Also, at the end of the study, each participant will be asked five questions regarding their perception/acceptance in relation to their quality of life, glycaemic control, the benefits and barriers of using the CGM. HbA1c will be recorded from pathology results at the commencement. Similarly, the follow up HbA1c will recorded at the end of the intervention. HbA1c will be measured in a NATA accredited laboratory. Participants will be provided with CGM kit at this time. All participants will be given an information kit with the following contents:
• The study procedure;
• Contact details of the diabetes dietitian, endocrinologist, credential diabetes educator, Gold Coast University Hospital Emergency Department;
• Food, blood glucose level and exercise diary;
• Sick day management plan;
• Support services (in the case they experience any psychological distress during the study) and
• Participant withdrawal form.

Diet:
Meal plans will be developed for each participant to meet their energy needs as per the Schofield formula (Schofield, 1985) and a macronutrient distribution of 20% for carbohydrate, 25% for protein and 55% for fat. This macronutrient distribution is similar to other studies where a low carbohydrate diet has been used (Ireland et al., 1992; Nielsen et al., 2005; Schmidt et al., 2019). Meals will not be provided to participants. Each participant will be provided with a tailored meal plan as per their total energy needs. Participant food likes and dislikes will be taken into account prior to developing the specific meal plan to reduce dietary boredom and/or fatigue.

On day one of the study, the participants will meet with diabetes dietitian and be provided with their specific dietary meal plans. Participants will be advised the importance of adhering to the meal plans to ensure accuracy of study outcomes. Any treatment for hypoglycaemia is to be recorded by the participant i.e. when, what and how much carbohydrate was used to treat the hypoglycaemic event. Diabetes dietitian follow up consultation via telephone will occur at week 2, 4, 6, 8, 10 to determine if the participant has any questions or concerns about the dietary intake and to troubleshoot any problems. Participants will be able to contact the diabetes dietitian via phone or email at any time if they have any questions or concerns. Participants will be encouraged to contact the Endocrinologist or CDE at any time via telephone or email if they have any questions or concerns about their blood glucose levels, CGM and/or feel their insulin needs adjusting. Once a week during the 12-week intervention phase, participants will be required to perform a blood ketone test the morning after an overnight fast. Participants will be provided with a sick day management plan and if feeling unwell should contact the Endocrinologist or CDE for advice immediately.
Intervention code [1] 316066 0
Lifestyle
Comparator / control treatment
Study procedure: Matched controls group:
Once a potential participant has agreed to participate in the study, they will complete an online PICF and diabetes specific quality of life questionnaire. This will be followed by a dietary consultation where “usual” care will be provided i.e. these participants will not be provided any intervention information i.e. the modified carbohydrate diet.

Evidence explains that usual care is a term used to describe the full spectrum of patient care practices in which clinicians can individualise care (Thompson & Schoenfeld, 2007). In this study “usual care” means that the participant will not receive or be treated with intervention advice i.e. provided with an individualised meal plan with a macronutrient distribution of 20% for carbohydrate, 25% for protein and 55% for fat, will not be in contact with the researcher fortnightly, will not wear a continuous glucose monitor, will not be instructed to check blood ketones levels weekly, will not track their steps using a fitness tracking device, will not need to weight or measure their foods/fluids to ensure they are adhering to their meal plan.

Furthermore, the matched controls group participants will report their typical dietary intake (foods and fluids) (breakfast, lunch, dinner, morning tea, afternoon tea and supper) and any other meals or snacks consumed during a 24 hour period. If the foods/fluids reported do not meet the Australian healthy eating dietary guidelines the matched controls participant will be counselled on how to change this based on the deficiency in their intake. For example, if the participant is only consuming one serve of dairy a day, they will be advised according to the Australian healthy eating dietary guidelines to aim to increase this to two to three serves a day with the reason why to make the change and examples of foods/fluids to assist the change. This is usual care, in the instance of this study.

The participant will then attend a follow-up appointment in 3 months’ time where they will complete the online diabetes specific quality of life questionnaire and participate in a dietary consultation to determine if any dietary changes had occurred in the past 3 months i.e changes in food/snack/drink choices, food/snack/drink portions and macronutrients (increased or decreased). HbA1c results will be obtained from pathology records. This dietary data and HbA1c results will be used to compared to the modified carbohydrate intervention group.
Control group
Active

Outcomes
Primary outcome [1] 321959 0
Primary outcome 1: % change in HbA1c
Timepoint:
Pre and post intervention (baseline and at 12 weeks after the intervention)
Instrument:
An EDTA whole blood sample will be collected for analysis. HbA1c will be measured by chromatography HPLC immunoassay using a BioRad D-100 analyser (Bio-Rad Laboratories Inc, USA). HbA1c will be reported in both % and mmol/mol (IFCC) units as per the International Federation of Clinical Chemistry (IFCC) reference method.
Timepoint [1] 321959 0
3 months (i.e. week 13 of the intervention) after the commencement of the intervention
Primary outcome [2] 321960 0
Primary outcome 2: % change in quality of life
Timepoint:
Pre and post intervention (baseline and at week 13 of the intervention)
Instrument: Validated Diabetes specific quality of life questionnaire specifically developed for this study.
Timepoint [2] 321960 0
3 months (i.e. week 13 of the intervention) after the commencement of the intervention
Secondary outcome [1] 376802 0
Nil
Timepoint [1] 376802 0
Nil

Eligibility
Key inclusion criteria
1. Male, female or unspecified gender;
2. 18 years of age or over;
3. Type 1 diabetes for equal to or greater than 1 year from diagnosis date and
4. Individuals who administer insulin using multiple daily injections.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with type 2 diabetes mellitus;
2. Patients with gestational diabetes mellitus;
3. Presence of a known food allergy or intolerance that may affect the participants’ health or adherence during the intervention;
4. History of an eating disorder;
5. BMI <18.5kg/m2;
6. BMI >25.0kg/m2;
7. Age <18 years;
8. An active medical problem that may hinder the persons’ ability to take part or potentially affect study outcomes e.g. a recent myocardial infarction, stroke or peripheral re-vasularisation (within 3 months), active treatment of diabetic retinopathy, recent serious infection (requiring in-hospital treatment or prolonged antibiotic therapy), active mental health complaint or other active medical problems determined by medical staff;
9. Pregnancy or expectation of conceiving. Participants will be withdrawn at any stage from the study if pregnancy occurs;
10. The use of medications that may affect body weight/body composition (including but not limited to phentermine and corticosteroids);
11. Those for whom the written materials may be unsuitable such as vision impaired or illiterate individuals;
12. Those unable to understand English;
13. Those who failed to provide informed consent and
14. Those who administer insulin using a CSII.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was determined by using a paired t-test at a 0.05 significance level and power of 0.8 to detect a significant clinical difference of 1.0% in HbA1c, 16 participants should complete the study. To account for a 40% attrition rate, a total of 23 participates will be recruited for the intervention (advice from Dr. Ian Hughes, Biostatistician, Gold Coast University Hospital).

To act as a control measure, a “matched controls group” will be recruited (n= 23). These participants will be matched with the intervention group for gender, age (within 10 years) and diabetes duration (within 5 years).

Statistical analysis will be conducted to determine if a direct association exists between:
• A modified carbohydrate intake and quality of life;
• A modified carbohydrate intake and glycaemic control;
• Glycaemic control and quality of life.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2020
Actual
Date of last participant enrolment
Anticipated
27/11/2020
Actual
Date of last data collection
Anticipated
27/02/2021
Actual
Sample size
Target
23
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 15148 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 28443 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 304262 0
Self funded/Unfunded
Name [1] 304262 0
Janine Paul
Country [1] 304262 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast University Hospital
Address
1 Hospital Boulevard
Southport QLD 4315
Country
Australia
Secondary sponsor category [1] 304505 0
University
Name [1] 304505 0
University of Canberra
Address [1] 304505 0
Kirinari Street
Bruce ACT 2617
Country [1] 304505 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304717 0
Gold Coast Health Human Resarch Ethic Committee
Ethics committee address [1] 304717 0
1 Hospital Boulevard
Southport QLD 4215
Ethics committee country [1] 304717 0
Australia
Date submitted for ethics approval [1] 304717 0
12/06/2019
Approval date [1] 304717 0
09/08/2019
Ethics approval number [1] 304717 0
HREC/2019/QGC/54049
Ethics committee name [2] 304730 0
University of Canberra Human Ethics Committee
Ethics committee address [2] 304730 0
Kirinari Street
Bruce ACT 2617
Ethics committee country [2] 304730 0
Australia
Date submitted for ethics approval [2] 304730 0
05/09/2019
Approval date [2] 304730 0
05/09/2019
Ethics approval number [2] 304730 0
HREC/2019/UC/2223

Summary
Brief summary
The aim of this study is to examine the association between a modified carbohydrate diet, quality of life and glycaemic control in adults living with type 1 diabetes mellitus. The study design is an cross-sectional, case control cohort study: pre and post intervention. The intervention group (n= 23) will undergo the modified carbohydrate diet for 12 weeks. The matched controls group (n= 23) will undergo "usual" care for 12 weeks. Each participant will complete the validated diabetes specific quality of life questionnaire and have their HbA1c collected pre and post the intervention period. This study will determine if a modified carbohydrate diet mediates the relationship between quality of life and glycaemic control in adults with T1DM.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97982 0
Miss Janine Paul
Address 97982 0
Gold Coast University Hospital and Health Service
1 Hospital Boulevard
Southport QLD 4215
Country 97982 0
Australia
Phone 97982 0
+61 488 049 040
Fax 97982 0
Email 97982 0
[email protected]
Contact person for public queries
Name 97983 0
Miss Janine Paul
Address 97983 0
Gold Coast University Hospital and Health Service
1 Hospital Boulevard
Southport QLD 4215
Country 97983 0
Australia
Phone 97983 0
+61 488 049 040
Fax 97983 0
Email 97983 0
[email protected]
Contact person for scientific queries
Name 97984 0
Miss Janine Paul
Address 97984 0
Gold Coast University Hospital and Health Service
1 Hospital Boulevard
Southport QLD 4215
Country 97984 0
Australia
Phone 97984 0
+61 488 049 040
Fax 97984 0
Email 97984 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
Due to the confidential and sensitive nature of the data collected no participant information will made available to anyone expect the research as outlined in the participant information and consent form.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5659Study protocol  [email protected] An alternative email address: [email protected]... [More Details]



Results publications and other study-related documents

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