None listed
Conditions
Brief summary
The increasing popularity of low carbohydrate diets in the community has meant that people with Type 1 Diabetes are adopting these diets, with the expectation of improved glucose control and weight loss. Where there is very limited research to guide this practice in people with Type 1 Diabetes, this project aims to assess whether lowering dietary carbohydrate improves glucose control and clinical outcomes for adults with Type 1 Diabetes Mellitus. This study is a randomized controlled study of adults with Type 1 Diabetes, that aims to compare the effect of a lower carbohydrate diet (average intake of less than 100g per day) with standard dietary recommendations (more than 150g per day) on glucose control, insulin doses, rates of hypoglycaemia, perceived quality of life and treatment satisfaction. We seek to explore potential mechanisms for changes in glucose control, focusing on the impact of dietary changes on the gut microbiome, intestinal epithelial permeability, body composition and inflammatory mediators. We hypothesise that intentional lowering of dietary carbohydrate will be associated with reduced dose requirement of insulin, reduced glucose variability and rates of hypoglycaemia, improved measures of perceived quality of life and alteration of gut microbiome. We expect to see a difference in the groups at 3 months, and will extend the intervention to 6 months to assess whether this dietary change is sustainable for people with Type 1 Diabetes. Participants will receive detailed education regarding carbohydrate counting, recommendations for meal plans that contain a reduced carbohydrate content and advice regarding insulin dose adjustments according to changing glucose levels. Close follow-up will be maintained by diabetes health care professionals. Data will be collected at baseline, 3 months and 6 months, to investigate traditional clinical outcomes - HbA1c, lipid profile, urinary protein and glucose variability as well as perceived quality of life. The effect of the dietary change will also be assessed on the intestinal microbiome, epithelial permeability and body composition.
Interventions
Intervention: Participants will receive dietary advice to actively lower average daily carbohydrate intake to less than 100g. Education will be provided by a dietitian with at least 5-years' clinical experience. The education session will be a 1-hour one-on-one session conducted in the hospital diabetes clinic, followed by two 30-minute follow-up sessions at 1 and 2 weeks post-randomization. The content will be based on the recommendations contained in the CSIRO Low Carbohydrate Diet, but ad
Intervention: Participants will receive dietary advice to actively lower average daily carbohydrate intake to less than 100g. Education will be provided by a dietitian with at least 5-years' clinical experience. The education session will be a 1-hour one-on-one session conducted in the hospital diabetes clinic, followed by two 30-minute follow-up sessions at 1 and 2 weeks post-randomization. The content will be based on the recommendations contained in the CSIRO Low Carbohydrate Diet, but adapted for use in the study by the research team. Personalized meal plans will be developed by the dietitian with each participant, including 4-6 meal options for breakfast, lunch and dinner along with options for snacks. A matching program of education regarding expected insulin dose reductions will be delivered by the Endocrinologist conducting the study. This will be provided in a 20-minute session following the dietitian education, and supported by personalized insulin dose recommendations in written format. Written information regarding lower carbohydrate diets, recipe options and guidelines for insulin dose adjustments will be provided in written and electronic format. Close follow-up will be provided to ensure safety and support to participants, through weekly phone or email contact for the first 4 weeks, and then fortnightly. The duration of the intervention will be 3 months (post randomization).
Sponsors
University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Age 18 - 80 Confirmed diagnosis of Type 1 Diabetes Basal bolus insulin regimen
Exclusion criteria
Pregnant or breastfeeding Recognised diagnosis of eating disorder Malabsorption syndrome eg. coeliac disease Stage 3-5 Chronic Kidney Disease Unwilling to attend clinic
Outcome results
None listed