Low Carbohydrate Diet, Glycaemic Control and Quality of Life in Australian Adults With Type 1 Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Other: Low carbohydrate diet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Low carbohydrate dietary group<br>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: Low carbohydrate diet<br>* 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) .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 12 weeks (post intervention) | 
| Glycaemic control (HbA1c) at baseline pre intervention | Baseline (pre intervention) in glycaemic control (HbA1c) | Baseline (pre intervention) | 
| Glycaemic control (HbA1c) | % change in glycaemic control from baseline to 12 weeks (post intervention) (HbA1c) | 12 weeks (pre and post intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of life, Glycaemic control, Low carbohydrate diet