None listed
Conditions
Brief summary
Obesity and high blood sugars are common in patients who require hip or knee replacement and are associated with poor outcomes such as infection. The study seeks to clarify if 6 weeks of dietary change in the form of the CSIRO's Low Carb Diet book can improve weight and blood sugar management around the time of surgery. Blood sugar will be monitored by a small wearable device known as a continuous glucose monitor. The hypothesis of the study is that 6 weeks of dietary change will improve patients blood sugars around the time of joint replacement.
Interventions
High blood sugars during a hip or knee replacement admission are associated with poor outcomes such as infection. This is common in patients with a diagnosis of diabetes, however also happens frequently in patients without a diagnosis of diabetes. This is likely due to the high numbers of undiagnosed diabetics within the community. The surgical stress also adds to the likelihood of high blood sugars. It is therefore a priority to identify and implement effective strategies that improve blood glu
High blood sugars during a hip or knee replacement admission are associated with poor outcomes such as infection. This is common in patients with a diagnosis of diabetes, however also happens frequently in patients without a diagnosis of diabetes. This is likely due to the high numbers of undiagnosed diabetics within the community. The surgical stress also adds to the likelihood of high blood sugars. It is therefore a priority to identify and implement effective strategies that improve blood glucose control in individuals undergoing hip and knee replacement surgery to improve patient outcomes. Dietary advice and management are the cornerstone of type 2 diabetes management and has been shown to have beneficial effects on weight loss and blood glucose control. The CSIRO Low Carbohydrate Diet book, which is a prescriptive, energy controlled meal plan based on rigorous clinical research, published in high-impact factor scientific journals has been shown to be an effective strategy for promoting weight loss and improving blood glucose control in patients with type 2 diabetes in the community setting. This project seeks to analyse the outcome of pre-operative dietary advice delivered cost-effectively via the CSIRO Low Carb Book and its effect on blood glucose control in patients around the time of hip and knee replacement surgery. Patients (both with type 2 diabetes, or without diabetes but overweight – BMI 28 – 40) will be randomized to their current habitual diet or the CSIRO’s Low Carbohydrate Diet for 6 weeks prior surgery. The intervention is to ask patients to follow the CSIRO's Low Carb Diet for 6 weeks before hip or knee replacement. Pre operative dietary advice will be administered by giving participants a copy of the CSIRO book only. The book will be given to them by their Orthopaedic Surgeon and they will be asked to read and follow the book for the 6 week period before surgery. Adherence to the diet will simply be inferred by the change in patients weight over the 6 week period.
Sponsors
Perth Orthopaedic & Sports Medicine Research Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
• Patient booked and suitable for unilateral hip or knee replacement • Age: 18 – 75 • BMI 28 – 40, with or without existing diagnosis of T2DM. • Smartphone compatible with Medtronic CGM (iPhone or Android)
Exclusion criteria
• Type 1 Diabetes or uncontrolled Type 2 Diabetes • BMI < 28 • Proteinuria • Abnormal liver (ALT / AST or GGT > 2.5 times normal limit) or renal function (eGFR < 60ml/ min) • Any abnormal or clinically significant history including: current malignancy, liver, respiratory, pregnancy / lactation, eating disorders • Significant endocrinopathy other than stable treated thyroid disease • Glucocorticoid use within the last 3 months • Patients who are newly diagnosed diabetics (previously not known to have diabetes) with a fasting BSL of >7.0 on the pre operative blood screen will be referred back to the General Practioner for commencement of standard diabetic management and will be excluded from the study.
Outcome results
None listed