Type 1 Diabetes MellitusNCT04213300
Low Carbohydrate Diet, Glycaemic Control and Quality of Life in Australian Adults With Type 1 Diabetes
An observational study of Type 1 Diabetes Mellitus, run by Gold Coast Hospital and Health Service at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Low carbohydrate diet
- Type of treatment
- Injection or infusion
- How many people
- 23 participants
- Where
- 1 siteAustralia
- Study dates
- 15 Jan 2021to 19 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * 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.
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Gold Coast Hospital and Health Service
Gold Coast, Queensland, 4215
About this study
Official 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
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.
Read the detailed description
Phase 1:
Aim: To develop a reliable and valid diabetes specific quality of life questionnaire for use in Australian adults living with type 1 diabetes mellitus (T1DM).
Objectives:
- To develop a new Australian diabetes specific quality of life online questionnaire integrating participant feedback using a one to one interview method;
- Pilot the study developed online questionnaire with adults that have type 1 diabetes mellitus and
- Conduct factorial validation of the study developed online questionnaire using advanced statistical modelling techniques.
Phase 2:
Aim: The aim of this study is to examine the association between a low carbohydrate diet, quality of life and glycaemic control in adults living with T1DM.
Objectives:
- To examine the association between quality of life and glycaemic control in adults with T1DM;
- Implement a low carbohydrate diet in a cohort of adults living with T1DM;
- Examine the association between a low carbohydrate diet and glycaemic control in adults with T1DM: pre and post intervention;
- Examine the association between quality of life and a low carbohydrate in adults with T1DM: pre and post intervention and
- Investigate whether a low carbohydrate diet mediates the relationship between quality of life and glycaemic control in adults with T1DM.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Low carbohydrate diet
- Keywords
- Quality of life, Glycaemic control, Low carbohydrate diet
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low carbohydrate dietOther
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) .
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Low carbohydrate diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self reported quality of life at baseline pre intervention
Baseline (pre intervention) participant self reported quality of life using the newly validated Australian diabetes specific quality of life questionnaire which uses a Likert scale of 1 = very strongly disagree to 10 = very strongly agree, from baseline to 12 weeks after intervention
Measured: Baseline (pre intervention)
Self reported quality of life at 12 weeks post intervention
% change in participant self reported quality of life from baseline to 12 weeks (post intervention) using the newly validated Australian diabetes specific quality of life questionnaire which uses a Likert scale of 1 = very strongly disagree to 10 = very strongly agree, from baseline to 12 weeks after intervention
Measured: 12 weeks (post intervention)
Glycaemic control (HbA1c) at baseline pre intervention
Baseline (pre intervention) in glycaemic control (HbA1c)
Measured: Baseline (pre intervention)
Glycaemic control (HbA1c)
% change in glycaemic control from baseline to 12 weeks (post intervention) (HbA1c)
Measured: 12 weeks (pre and post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start15 Jan 2021
- Primary completion19 Nov 2021
- Study completion19 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gold Coast Hospital and Health Service
- Sponsor type
- Other government
- Collaborators
- University of Canberra
- Responsible party
- Sponsor
- Investigators
- Janine Paul, MSc, Principal investigator, Gold Coast Hospital and Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213300
- Sponsor's protocol ID
- HREC/2019/QGC/54049
- Status last verified
- Nov 2021
- First submitted
- 27 Nov 2019
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Paul J, Jani R, Davoren P, Knight-Agarwal C. Association Between a Low Carbohydrate Diet, Quality of Life, and Glycemic Control in Australian Adults Living With Type 1 Diabetes: Protocol for a Mixed Methods Pilot Study. JMIR Res Protoc. 2021 Mar 26;10(3):e25085. doi: 10.2196/25085.
PubMed 33769300
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04213300
- Acronym / sponsor ID
- HREC/2019/QGC/54049
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Quality of life, Glycaemic control, Low carbohydrate diet
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Gold Coast Hospital and Health ServiceOther government
- Collaborators
- University of Canberra
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 19 Nov 2021 (actual)
- Study completion
- 19 Nov 2021 (actual)
- First posted
- 30 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Phase 1:
Aim: To develop a reliable and valid diabetes specific quality of life questionnaire for use in Australian adults living with type 1 diabetes mellitus (T1DM).
Objectives:
- To develop a new Australian diabetes specific quality of life online questionnaire integrating participant feedback using a one to one interview method;
- Pilot the study developed online questionnaire with adults that have type 1 diabetes mellitus and
- Conduct factorial validation of the study developed online questionnaire using advanced statistical modelling techniques.
Phase 2:
Aim: The aim of this study is to examine the association between a low carbohydrate diet, quality of life and glycaemic control in adults living with T1DM.
Objectives:
- To examine the association between quality of life and glycaemic control in adults with T1DM;
- Implement a low carbohydrate diet in a cohort of adults living with T1DM;
- Examine the association between a low carbohydrate diet and glycaemic control in adults with T1DM: pre and post intervention;
- Examine the association between quality of life and a low carbohydrate in adults with T1DM: pre and post intervention and
- Investigate whether a low carbohydrate diet mediates the relationship between quality of life and glycaemic control in adults with T1DM.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low carbohydrate dietary group | – | Other: Low carbohydrate dietParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low carbohydrate dietStudy 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) . | Other | Low carbohydrate dietary group |
Primary outcome
Self reported quality of life at baseline pre intervention
Time frame: Baseline (pre intervention)
Baseline (pre intervention) participant self reported quality of life using the newly validated Australian diabetes specific quality of life questionnaire which uses a Likert scale of 1 = very strongly disagree to 10 = very strongly agree, from baseline to 12 weeks after intervention
Self reported quality of life at 12 weeks post intervention
Time frame: 12 weeks (post intervention)
% change in participant self reported quality of life from baseline to 12 weeks (post intervention) using the newly validated Australian diabetes specific quality of life questionnaire which uses a Likert scale of 1 = very strongly disagree to 10 = very strongly agree, from baseline to 12 weeks after intervention
Glycaemic control (HbA1c) at baseline pre intervention
Time frame: Baseline (pre intervention)
Baseline (pre intervention) in glycaemic control (HbA1c)
Glycaemic control (HbA1c)
Time frame: 12 weeks (pre and post intervention)
% change in glycaemic control from baseline to 12 weeks (post intervention) (HbA1c)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
- Derived from this study: PubMed 33769300Paul J, Jani R, Davoren P, Knight-Agarwal C. Association Between a Low Carbohydrate Diet, Quality of Life, and Glycemic Control in Australian Adults Living With Type 1 Diabetes: Protocol for a Mixed Methods Pilot Study. JMIR Res Protoc. 2021 Mar 26;10(3):e25085. doi: 10.2196/25085.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janine Paul, MSc principal investigator
Gold Coast Hospital and Health Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus, run by Gold Coast Hospital and Health Service at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self reported quality of life at baseline pre intervention (time frame: Baseline (pre intervention)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04213300, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2021.