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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04213300
Ethics application status
Date submitted
27/11/2019
Date registered
30/12/2019

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
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
Government body
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data collected in this study is specific to this doctoral research project. Therefore, there will be no data sharing with any other researchers who are not members of this study. Where a current research team member wishes to use any of this data research purposes, the research must be approved by an Ethics committee, involve the PI who will ultimately retain oversight of all future uses of data and will remain the ongoing custody of data and/or research outputs.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04213300