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

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Other: Low carbohydrate diet

• Registration Number: NCT04213300
• Lead Sponsor: Gold Coast Hospital and Health Service

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.

Study Timeline

• Study First Submitted: 2019-11-27
• Study First Submitted QC: 2019-12-26
• Study First Posted: 2019-12-30
• Study Start: 2021-01-15
• Status Verified: 2021-11
• Primary Completion: 2021-11-19
• Study Completion: 2021-11-19
• Last Update Submitted: 2021-11-19
• Last Update Posted: 2021-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low carbohydrate dietary group	Low carbohydrate diet	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.

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Gold Coast Hospital and Health Service; 🇦🇺 Gold Coast, Queensland, Australia