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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Self reported quality of life at baseline pre intervention
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Self reported quality of life at baseline pre intervention
时间窗: 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
时间窗: 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
时间窗: Baseline (pre intervention)
Baseline (pre intervention) in glycaemic control (HbA1c)
Glycaemic control (HbA1c)
时间窗: 12 weeks (pre and post intervention)
% change in glycaemic control from baseline to 12 weeks (post intervention) (HbA1c)
次要结局
未报告次要终点