Clinical trial NCT04213300: Low Carbohydrate Diet, Glycaemic Control and Quality of Life in Australian Adults With Type 1 Diabetes
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus
Keywords: Quality of life
Glycaemic control
Low carbohydrate diet
Lead sponsor: Gold Coast Hospital and Health Service
Sponsor class: OTHER_GOV
Collaborators: name: University of Canberra
First posted: 2019-12-30
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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.

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.

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:

1. To develop a new Australian diabetes specific quality of life online questionnaire integrating participant feedback using a one to one interview method;
2. Pilot the study developed online questionnaire with adults that have type 1 diabetes mellitus and
3. 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:

1. To examine the association between quality of life and glycaemic control in adults with T1DM;
2. Implement a low carbohydrate diet in a cohort of adults living with T1DM;
3. Examine the association between a low carbohydrate diet and glycaemic control in adults with T1DM: pre and post intervention;
4. Examine the association between quality of life and a low carbohydrate in adults with T1DM: pre and post intervention and
5. Investigate whether a low carbohydrate diet mediates the relationship between quality of life and glycaemic control in adults with T1DM.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Self reported quality of life at baseline pre intervention
timeFrame: Baseline (pre intervention)
measure: Self reported quality of life at 12 weeks post intervention
timeFrame: 12 weeks (post intervention)
measure: Glycaemic control (HbA1c) at baseline pre intervention
timeFrame: Baseline (pre intervention)
measure: Glycaemic control (HbA1c)
timeFrame: 12 weeks (pre and post intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Gold Coast
country: Australia
facility: Gold Coast Hospital and Health Service
state: Queensland
Study officials:
affiliation: Gold Coast Hospital and Health Service
name: Janine Paul, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.