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

Gold Coast Hospital and Health Service

Status: Completed

Conditions: Type 1 Diabetes Mellitus

Treatments: Other: Low carbohydrate diet

Study type: Observational

Funder types: Other

Identifiers

NCT04213300

HREC/2019/QGC/54049

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

23 participants in 1 patient group

Low carbohydrate dietary group

Description:

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.

Treatment:

Other: Low carbohydrate diet