Type 1 Diabetes Mellitus
Conditions
Keywords
Quality of life, Glycaemic control, Low carbohydrate diet
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.
Interventions
OTHERLow 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) .
Sponsors
University of Canberra
Gold Coast Hospital and Health Service
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self reported quality of life at baseline pre intervention | 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 | 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 | Baseline (pre intervention) | Baseline (pre intervention) in glycaemic control (HbA1c) |
| Glycaemic control (HbA1c) | 12 weeks (pre and post intervention) | % change in glycaemic control from baseline to 12 weeks (post intervention) (HbA1c) |
Countries
Australia
Outcome results
None listed