Currently submitted to: JMIR Research Protocols
Date Submitted: Oct 16, 2020
Open Peer Review Period: Oct 16, 2020 - Dec 11, 2020
(currently open for review)
The Association between a Low Carbohydrate Diet, Quality of Life and Glycemic Control in Australian Adults living with Type 1 Diabetes: A Pilot Study Protocol
Globally, the prevalence of type 1 diabetes (T1DM) is rising. In 2020, 124,652 Australians had T1DM. Maintaining optimal glycemic control [HbA1c ≤7.0% (≤53 mmol/mol)] on a standard carbohydrate diet can be a challenge for people living with T1DM. The Diabetes Complications and Control Trial established that macrovascular and microvascular complications could be reduced by improving glycemic control. Recent studies have found that a very low or low carbohydrate diet can improve glycemic control. However, the overall evidence relating to an association between a very low or low carbohydrate diet and glycemic control in people living with T1DM is both limited and mixed. In addition, research has suggested that poor quality of life (QoL) due to anxiety and depression adversely influences glycemic control. Despite a potential link between a very low or low carbohydrate diet and good glycemic control, no research to our knowledge has examined an association between a very low or low carbohydrate diet, QoL and glycemic control, making this study unique in its approach.
The study aims to: 1) develop a validated diabetes specific quality of life questionnaire for use in Australian adults with T1DM and 2) determine if an association exists between a low carbohydrate diet, quality of life and glycemic control in Australian adults living with T1DM.
This cross-sectional study will be conducted in a tertiary hospital outpatient setting and will consist of three phases. Phase 1, online Australian diabetes specific quality of life questionnaire development and piloting (n=25-30 T1DM adults); Phase 2, questionnaire validation (n=364 T1DM adults) and Phase 3, a 12-week dietary intervention to determine if an association exists between a low carbohydrate diet, QoL and glycemic control in adults with T1DM (n=16-23 T1DM adults). The validation of the study developed Australian diabetes specific quality of life questionnaire and change in HbA1c and QoL in adults with T1DM while undertaking a low carbohydrate diet over 12 weeks will be the primary outcomes of this study.
No results are currently available.
This study is the first of its kind and will firstly generate a new validated instrument, which could be used in evidence-based practice and research to understand T1DM adults QoL. Secondly, the low carbohydrate dietary intervention outcomes could be used to inform clinicians about an alternative approach to assist T1DM Australian adults to improve their QoL and glycemic control. Finally, this study could warrant the development of an evidence based low carbohydrate dietary guideline for adults living with T1DM with the potential to have a profound impact on this population. Clinical Trial: ClinicalTrials.gov NCT04213300; https://www.clinicaltrials.gov/ct2/show/NCT04213300
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