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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04213300




Registration number
NCT04213300
Ethics application status
Date submitted
27/11/2019
Date registered
30/12/2019
Date last updated
2/12/2021

Titles & IDs
Public title
Low Carbohydrate Diet, Glycaemic Control and Quality of Life in Australian Adults With Type 1 Diabetes
Scientific title
The Association Between a Low Carbohydrate Diet, Glycaemic Control and Quality of Life in Australian Adults Living With Type 1 Diabetes Mellitus: A Pilot Study
Secondary ID [1] 0 0
HREC/2019/QGC/54049
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Low carbohydrate diet

Low carbohydrate dietary group - Participants n = 23
Participants:
Male, female or unspecified gender;
18 years of age or over;
Type 1 diabetes for =1 year from diagnosis date and
Individuals who administer insulin using multiple daily injections.


Other interventions: Low carbohydrate diet
Study duration: 13 weeks (run in phase = 1 week; low carbohydrate diet phase = 12 weeks).
Each participant will be provided with an individualised meal plans to meet their energy needs as per the Schofield formula and a macronutrient distribution of 20% for carbohydrate, 25% for protein and 55% for fat.
Participants will self-report quality of life using a validated diabetes specific quality of life questionnaire for Australian adults and HbA1c (pre and post intervention phase of 13 weeks duration) .
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Self reported quality of life at baseline pre intervention
Timepoint [1] 0 0
Baseline (pre intervention)
Primary outcome [2] 0 0
Self reported quality of life at 12 weeks post intervention
Timepoint [2] 0 0
12 weeks (post intervention)
Primary outcome [3] 0 0
Glycaemic control (HbA1c) at baseline pre intervention
Timepoint [3] 0 0
Baseline (pre intervention)
Primary outcome [4] 0 0
Glycaemic control (HbA1c)
Timepoint [4] 0 0
12 weeks (pre and post intervention)

Eligibility
Key inclusion criteria
- Male, female or unspecified gender;

- 18 years of age or over;

- Type 1 diabetes for =1 year from diagnosis date and

- 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?
Yes
Key exclusion criteria
- Patients with type 2 diabetes mellitus;

- Patients with gestational diabetes mellitus;

- Presence of a known food allergy or intolerance that may affect the participants'
health or adherence during the intervention;

- History of an eating disorder;

- BMI <25.0kg/m2 to 29.9kg/m2;

- Age <18 years;

- 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 revascularisation (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;

- Pregnancy or expectation of conceiving. Participants will be withdrawn at any stage
from the study if pregnancy occurs;

- The use of medications that may affect body weight/body composition (including but not
limited to phentermine and corticosteroids);

- Those for whom the written materials may be unsuitable such as vision impaired or
illiterate individuals;

- Those unable to understand English;

- Those who failed to provide informed consent and

- Those who administer insulin using a continuous subcutaneous insulin infusion.

Study design
Purpose
Duration
Cross-sectional
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/11/2021
Sample size
Target
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Gold Coast Hospital and Health Service - Gold Coast
Recruitment postcode(s) [1] 0 0
4215 - Gold Coast

Funding & Sponsors
Primary sponsor type
Other
Name
Gold Coast Hospital and Health Service
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Canberra
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The aim of this study is to examine the association between a low carbohydrate diet, quality
of life and glycaemic control in Australian adults with T1DM. The first phase of the study
will develop and validate a diabetes specific quality of life questionnaire for adults with
T1DM. The second phase will undertake a low carbohydrate diet intervention and examine its
association with quality of life and glycaemic control, pre and post the dietary
intervention. The novel outcomes will include a new validated Australian T1DM specific
quality of life questionnaire and an investigation as to whether a low carbohydrate diet
mediates the relationship between quality of life and glycaemic control in Australian adults
with T1DM.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04213300
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janine Paul, MSc
Address 0 0
Gold Coast Hospital and Health Service
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04213300