The association between a modified carbohydrate diet, quality of life and glycaemic control in Australian adults with type 1 diabetes mellitus: A pilot study

Not Applicable

• Conditions: Type 1 Diabetes Mellitus; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12619001676101
• Lead Sponsor: Gold Coast University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-29
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

1. Male, female or unspecified gender;
2. 18 years of age or over;
3. Type 1 diabetes for equal to or greater than 1 year from diagnosis date and
4. Individuals who administer insulin using multiple daily injections.

Exclusion Criteria

1. Patients with type 2 diabetes mellitus;
2. Patients with gestational diabetes mellitus;
3. Presence of a known food allergy or intolerance that may affect the participants’ health or adherence during the intervention;
4. History of an eating disorder;
5. BMI <18.5kg/m2;
6. BMI >25.0kg/m2;
7. Age <18 years;
8. 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 re-vasularisation (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;
9. Pregnancy or expectation of conceiving. Participants will be withdrawn at any stage from the study if pregnancy occurs;
10. The use of medications that may affect body weight/body composition (including but not limited to phentermine and corticosteroids);
11. Those for whom the written materials may be unsuitable such as vision impaired or illiterate individuals;
12. Those unable to understand English;
13. Those who failed to provide informed consent and
14. Those who administer insulin using a CSII.

Study & Design

• Study Type: Interventional
• Study Design: Not specified