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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04213300
• Other study ID #: HREC/2019/QGC/54049
• Status: Completed
• Start date: January 15, 2021
• Est. completion date: November 19, 2021

Study information

• Verified date: November 2021
• Source: Gold Coast Hospital and Health Service
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 19, 2021
• Est. primary completion date: November 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Other:
• Low 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) .

Locations

Country	Name	City	State
Australia	Gold Coast Hospital and Health Service	Gold Coast	Queensland

Sponsors (2)

Lead Sponsor	Collaborator
Gold Coast Hospital and Health Service	University of Canberra

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	Glycaemic control (HbA1c) at baseline pre intervention	Baseline (pre intervention) in glycaemic control (HbA1c)	Baseline (pre intervention)
Primary	Glycaemic control (HbA1c)	% change in glycaemic control from baseline to 12 weeks (post intervention) (HbA1c)	12 weeks (pre and post intervention)