ow Carbohydrate Diet & Blood Sugar Control in Joint Replacement

Not Applicable

• Conditions: Osteoarthritis; Obesity; Hyperglycaemia; Surgery - Other surgery; Diet and Nutrition - Obesity; Metabolic and Endocrine - Other metabolic disorders; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12620000003976
• Lead Sponsor: Perth Orthopaedic & Sports Medicine Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fasting blood sugar during inpatient stay after hip or knee replacement.[Inpatient stay - 5 to 7 days.]

Secondary Outcome Measures

Name	Time	Method
Continuous Glucose Monitoring - A small painless sensor will be worn which records continuous glucose levels.[10 days (Lifespan of sensor) post surgery. The Continuous Glucose Monitor will be inserted during surgery and will remain in situ until the first post-operative visit 10 days later.];Change in bodyweight which will be measured by digital scale and recorded in the medical records.[6 weeks post commencement of dietary change. Patients will be instructed to change their diet 6 weeks before surgery and a weight will be recorded then. A weight will be recorded 6 weeks later on the day the patient is due to have surgery to assess the change in weight.];Long term fasting blood sugar assessed by finger prick blood glucometer testing.[2, 5 and 10 years post surgery.]