NCT04213300

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 23 (actual)
• Sponsor: Gold Coast Hospital and Health Service · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
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) .

Timeline

• Start date: 2021-01-15
• Primary completion: 2021-11-19
• Completion: 2021-11-19
• First posted: 2019-12-30
• Last updated: 2021-12-02

Locations

1 site across 1 country: Australia