Low Carbohydrate Diet, Glycaemic Control and Quality of Life in Australian Adults With Type 1 Diabetes
NCT ID: NCT04213300
Last Updated: 2021-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
23 participants
OBSERVATIONAL
2021-01-15
2021-11-19
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Low carbohydrate dietary group
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.
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) .
Interventions
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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) .
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
Yes
Sponsors
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University of Canberra
OTHER
Gold Coast Hospital and Health Service
OTHER_GOV
Responsible Party
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Principal Investigators
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Janine Paul, MSc
Role: PRINCIPAL_INVESTIGATOR
Gold Coast Hospital and Health Service
Locations
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Gold Coast Hospital and Health Service
Gold Coast, Queensland, Australia
Countries
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References
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Paul J, Jani R, Davoren P, Knight-Agarwal C. Association Between a Low Carbohydrate Diet, Quality of Life, and Glycemic Control in Australian Adults Living With Type 1 Diabetes: Protocol for a Mixed Methods Pilot Study. JMIR Res Protoc. 2021 Mar 26;10(3):e25085. doi: 10.2196/25085.
Other Identifiers
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HREC/2019/QGC/54049
Identifier Type: -
Identifier Source: org_study_id