Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000003976p
Ethics application status
Not yet submitted
Date submitted
29/10/2019
Date registered
8/01/2020
Date last updated
8/01/2020
Date data sharing statement initially provided
8/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Low Carbohydrate Diet & Blood Sugar Control in Joint Replacement
Scientific title
A Randomised Control Trial of a Low Carbohydrate versus Standard Habitual Diet for the Management of Perioperative Glycaemic Control in Hip and Knee Replacement
Secondary ID [1] 299662 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis
 314998 0
Obesity 314999 0
Hyperglycaemia 315000 0
Condition category
Condition code
Surgery 313336 313336 0 0
Other surgery
Diet and Nutrition 313410 313410 0 0
Obesity
Metabolic and Endocrine 313411 313411 0 0
Other metabolic disorders
Musculoskeletal 313412 313412 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 315924 0
Lifestyle
Comparator / control treatment
Patients will be asked to follow their normal, habitual diet.
Control group
Active

Outcomes
Primary outcome [1] 321815 0
Fasting blood sugar during inpatient stay after hip or knee replacement.
Timepoint [1] 321815 0
Inpatient stay - 5 to 7 days.
Secondary outcome [1] 376297 0
Continuous Glucose Monitoring - A small painless sensor will be worn which records continuous glucose levels.
Timepoint [1] 376297 0
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.
Secondary outcome [2] 376298 0
Change in bodyweight which will be measured by digital scale and recorded in the medical records.
Timepoint [2] 376298 0
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.
Secondary outcome [3] 376299 0
Long term fasting blood sugar assessed by finger prick blood glucometer testing.
Timepoint [3] 376299 0
2, 5 and 10 years post surgery.

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A concealed allocation procedure will be used, whereby only the study coordinator had access to the randomization list.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomized using a random number generator via Excel (Microsoft, Redmond, Washington), which allocates a ‘1 (???)’ or ‘2(???)’. A concealed allocation procedure will be used, whereby only the study coordinator had access to the randomization list. The investigators will receive individual envelopes containing the treatment allocation for each participant.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2020
Actual
Date of last participant enrolment
Anticipated
1/06/2024
Actual
Date of last data collection
Anticipated
1/06/2034
Actual
Sample size
Target
46
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 15063 0
Hollywood Private Hospital - Nedlands
Recruitment postcode(s) [1] 28353 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 304135 0
Hospital
Name [1] 304135 0
Hollywood Private Hospital
Country [1] 304135 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Perth Orthopaedic & Sports Medicine Research Institute
Address
31 Outram St
West Perth
Western Australia
6005
Country
Australia
Secondary sponsor category [1] 304366 0
None
Name [1] 304366 0
Address [1] 304366 0
Country [1] 304366 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 304618 0
Ramsay HREC WA
Ethics committee address [1] 304618 0
Research Administrator
Hollywood Private Hospital
Monash Ave, Nedlands,
Western Australia, 6009
Ethics committee country [1] 304618 0
Australia
Date submitted for ethics approval [1] 304618 0
14/02/2020
Approval date [1] 304618 0
Ethics approval number [1] 304618 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97606 0
Dr Daniel Meyerkort
Address 97606 0
Perth Orthopaedic & Sports Medicine Centre
31 Outram St
West Perth, 6006
Western Australia
Country 97606 0
Australia
Phone 97606 0
+61 0892124200
Fax 97606 0
Email 97606 0
[email protected]
Contact person for public queries
Name 97607 0
Dr Daniel Meyerkort
Address 97607 0
Perth Orthopaedic & Sports Medicine Centre
31 Outram St
West Perth, 6006
Western Australia
Country 97607 0
Australia
Phone 97607 0
+61 0892124200
Fax 97607 0
Email 97607 0
[email protected]
Contact person for scientific queries
Name 97608 0
Dr Daniel Meyerkort
Address 97608 0
Perth Orthopaedic & Sports Medicine Centre
31 Outram St
West Perth, 6006
Western Australia
Country 97608 0
Australia
Phone 97608 0
+61 0892124200
Fax 97608 0
Email 97608 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All data will be available
-Weight
-Fasting blood sugar
-Continuous Glucose Monitoring data
-Patient reported outcome measures
When will data be available (start and end dates)?
IPD will be available from the date of publication for a further 10 years.
Available to whom?
Journals and available to check scientific validity. IPD will be available for researchers who want to conduct meta-analysis.
Available for what types of analyses?
IPD data will be available for meta-analysis.
How or where can data be obtained?
IPD data may be accessed by contacting the principle investigator by email, telephone or post.

The contact email is [email protected]


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5479Study protocol    378637-(Uploaded-23-12-2019-18-14-52)-Study-related document.docx


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5479Ethical approval  [email protected] 378637-(Uploaded-13-07-2020-10-25-44)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.