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Trial registered on ANZCTR


Registration number
ACTRN12613000497707
Ethics application status
Not yet submitted
Date submitted
28/04/2013
Date registered
6/05/2013
Date last updated
6/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Very low calorie diet in cardiac surgery patients with obesity and metabolic syndrome: short and mid-term outcomes
Scientific title
A study on the short and mid-term outcomes following use of a preoperative very low calorie diet program in elective cardiac surgery patients with obesity and metabolic syndrome
Secondary ID [1] 282404 0
Nil
Universal Trial Number (UTN)
U1111-1142-4000
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elective cardiac surgery 288987 0
Obesity 289028 0
Metabolic syndrome 289029 0
Condition category
Condition code
Diet and Nutrition 289363 289363 0 0
Obesity
Surgery 289364 289364 0 0
Other surgery
Cardiovascular 289365 289365 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We aim to investigate the feasibility and outcomes of a preoperative supervised very low calorie diet (VLCD) program in elective cardiac surgery patients with obesity and the metabolic syndrome.

All elective cardiac surgery patients who are obese (WHO BMI criteria / waist circumference) and have the metabolic syndrome (modified NCEP-ATP III criteria of hypertension, high cholesterol and treated diabetes mellitus) will be invited to participate in a supervised very low calorie diet program for six weeks preoperatively. The initial two weeks will utilise a VLCD only (3 liquid meal replacements / day, approx 800 calories / day). Whole foods will then be added over the subsequent four weeks using the Healthy Eating Plan devised by the Nutrition and Dietetics Department. The participants will be reviewed by a Dietician and Endocrinologist (diabetic patients only) upon recruitment to provide information regarding the VLCD program. They will be reviewed again by the Dietician at two weeks for reintroduction of whole foods. Diabetic patients will be monitored by the Endocrinologist weekly if their blood sugars are erratic or if they require changes to medications. Blood tests will be performed both on recruitment and preoperatively (approximately six weeks after VLCD use).

No specific strategies will be employed to improve compliance. Encouragement will be provided during follow-up phone calls. Perioperative management will be conducted in a routine manner.

We will analyse short and mid-term outcomes including weight loss, postoperative mortality, morbidity and length of stay. Patients will be contacted either by phone or mail, at 6 and 12 months post-operatively to complete a follow-up questionnaire. These results will be compared with retrospective data for: elective cardiac surgery patients (all-comers), elective obese cardiac surgery patients without metabolic syndrome, and elective obese cardiac surgery patients with metabolic syndrome who did not undergo the VLCD intervention.
Intervention code [1] 287038 0
Lifestyle
Comparator / control treatment
Data will be compared with existing retrospective data for elective cardiac surgery patients (all-comers), elective obese cardiac surgery patients without metabolic syndrome and elective obese cardiac surgery patients with metabolic syndrome.

This data is de-identified and contained within the Department of Cardiothoracic Surgery (Princess Alexandra Hospital) audit database. Comparison data from the previous 12-18 months will be used to analyse the VLCD results.
Control group
Historical

Outcomes
Primary outcome [1] 289440 0
Weight change (kg)

Examples
- weight at recruitment minus weight following completion of VLCD OR
- weight at recruitment minus weight at follow-up (6 and 12 months post-operatively)
Timepoint [1] 289440 0
At recruitment
After completion of VLCD
At follow-up (6 and 12 months post-operatively)
Primary outcome [2] 289441 0
30 day morbidity, including:
- Major Adverse Cardiac or Cerebrovascular Events (MACE) including myocardial infarction, stroke, need for revascularisation
- New arrhythmia, pacemaker insertion
- Respiratory complication (e.g. prolonged intubation, pneumonia, pleural effusion/pneumothorax)
- Sepsis
- Wound complications
- Venous thromboembolism

Compared with rates of above for retrospective data (locally maintained audit database within Department of Cardiothoracic Surgery, Princess Alexandra Hospital) over previous 12-18 months
Timepoint [2] 289441 0
Within 30 days of surgery
Primary outcome [3] 289442 0
30 day mortality
Timepoint [3] 289442 0
Within 30 days of surgery
Secondary outcome [1] 302480 0
Length of stay (days)
- calculated from date of admission to date of discharge
Timepoint [1] 302480 0
Calculated after discharge from hospital
Secondary outcome [2] 302481 0
Improved blood pressure / lipid profile / HbA1c
- blood pressure measured
- blood tests taken after completion of VLCD program will be compared with results of blood tests taken at recruitment
Timepoint [2] 302481 0
At recruitment
After completion of VLCD
Secondary outcome [3] 302482 0
Intraoperative complications
- e.g. bleeding, myocardial infarction, stroke, allergy, graft failure

Assess by chart review
Timepoint [3] 302482 0
Post discharge from hospital
Secondary outcome [4] 302483 0
Medication requirement
- comparison between medication list and dosages at recruitment versus after completion of VLCD and at follow-up (6 to 12 months post-operatively)
Timepoint [4] 302483 0
Baseline medications recorded at recruitment
Medication list and dosages recorded and compared with baseline after completion of VLCD
Medication list and dosages recorded and compared with baseline at follow-up (6 to 12 months post-operatively)
Secondary outcome [5] 302484 0
Mid-term morbidity
- Major Adverse Cardiac or Cerebrovascular Events (MACE) including myocardial infarction, stroke, need for revascularisation
- New arrhythmia, pacemaker insertion
- Respiratory complication (e.g. prolonged intubation, pneumonia, pleural effusion/pneumothorax)
- Sepsis
- Wound complications
- Venous thromboembolism

Compared with rates of above for retrospective data (locally maintained audit database within Department of Cardiothoracic Surgery, Princess Alexandra Hospital) over previous 12-18 months
Timepoint [5] 302484 0
At follow-up (6 and 12 months post-operatively)
Secondary outcome [6] 302485 0
All cause mortality
Timepoint [6] 302485 0
At follow-up (6 and 12 months post-operatively)

Eligibility
Key inclusion criteria
Elective cardiac surgery patients
Aged 30-75 years
Obese (WHO BMI criteria, waist measurements)
Metabolic syndrome (modified NCEP-ATP III criteria)
Minimum age
30 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-elective cardiac surgery patients
Minors/children and patients >75 years
Pregnant women
Patients with cognitive/intellectual disability or mental illness
Patients from non-English speaking background
Diabetic patients on insulin therapy
Patients who are otherwise unable to complete six weeks VLCD program

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be recruited by specially instructed nursing or medical staff after they present to the outpatient clinic or undergo inpatient review, and are found to require non-urgent cardiac surgery. All patients will have their BMI calculated and waist circumference measured to identify those who meet the obesity criteria. Patients with metabolic syndrome will then be identified through history and/or examination, according to the modified NCEP-ATP III criteria (hypertension, elevated cholesterol, diabetes). They will be given the Participant Information Sheet and other supplemental information to enable informed consent. They will be given the opportunity to discuss their participation with carers or family members. Upon recruitment, they will be reviewed by the Dietician and Endocrinologist (diabetic patients only), given supporting documentation and commenced on the VLCD program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Patients will complete six weeks of preoperative VLCD program.

They will commence VLCD only for two weeks, then be reviewed again by Dietician and Endocrinologist (diabetic patients only). They will then have whole foods reintroduced (Healthy Eating Plan with suitable foods list provided) for the remaining four weeks.

They will be contacted weekly via phone to assess their progress and resolve any issues they may have encountered. The Endocrinology team will also monitor their blood glucose levels weekly, if their BSLs have been erratic or they are requiring significant modification of their diabetic medications.

On presentation for their elective cardiac surgery, patient progress will be monitored through physical measurements and blood results (lipid profile, cholesterol level). Routine perioperative management will be performed. Patients will be followed up at six and twelve months for mid-term outcomes.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The number of participants needed to achieve study objectives was based on clinical assumptions; the researchers believe that 200 patients should allow for extrapolation of results. Based on the existing patient database (maintained locally by the Department), we found approx 40-50 patients met the recruitment criteria (obesity and metabolic syndrome) annually. Therefore, we assume that a similar number of patients will be recruited yearly during the trial. Ideally, larger numbers will be recruited per year, or the study period may be lengthened to allow for greater sample size.

Results will be compared with existing retrospective data (local audit database maintained by the Department) for the past 12-18 months on:
- elective cardiac surgery patients (all-comers)
- elective cardiac surgery patients with obesity but not metabolic syndrome
- elective cardiac surgery patients with obesity and metabolic syndrome (predating the intervention)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 955 0
Princess Alexandra Hospital - Woolloongabba

Funding & Sponsors
Funding source category [1] 287177 0
Charities/Societies/Foundations
Name [1] 287177 0
Australian and New Zealand Society for Cardiac and Thoracic Surgeons (ANZSCTS) Foundation
Country [1] 287177 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Australian and New Zealand Society of Cardiac and Thoracic Surgeons
Address
ANZSCTS
Suite 512, Eastpoint
180 Ocean St,
Edgecliff NSW 2027
Country
Australia
Secondary sponsor category [1] 285942 0
None
Name [1] 285942 0
Address [1] 285942 0
Country [1] 285942 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289173 0
Metro South Health Service District HREC (EC00167)
Ethics committee address [1] 289173 0
HREC Office
Level 7
Translational Research Institute
37 Kent St
Woolloongabba QLD 4102
Ethics committee country [1] 289173 0
Australia
Date submitted for ethics approval [1] 289173 0
18/04/2013
Approval date [1] 289173 0
Ethics approval number [1] 289173 0
HREC/13/QPAH/233 SSA/13/QPAH/246

Summary
Brief summary
Patients will be recruited in the outpatient setting after they have been found to require cardiac surgery. They will have their body mass index (BMI) and waist circumference measured and will have blood tests. They will be reviewed by the Dietician, who will explain the very low calorie diet (VLCD) program. They will undergo the VLCD program, comprising liquid meal replacements for two weeks. They will then return for review by the Dietician and will be commenced on a Healthy Eating Plan, allowing for reintroduction of whole foods over the following four weeks. Diabetic patients will be monitored by the Endocrinology team throughout the period. On completing the program, they will be admitted for elective cardiac surgery and undergo routine preoperative assessment including repeat blood tests and calculation of their weight loss. They will be reviewed as an outpatient six weeks postoperatively. They will be contacted via phone or mail at 6 and 12 months postoperatively to assess mid-term outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39598 0
Dr Lucy Marney
Address 39598 0
Dept of Cardiothoracic Surgery
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba QLD 4102
Country 39598 0
Australia
Phone 39598 0
+61731762111
Fax 39598 0
Email 39598 0
l.marney@gmail.com
Contact person for public queries
Name 39599 0
Dr Lucy Marney
Address 39599 0
Dept of Cardiothoracic Surgery
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba QLD 4102
Country 39599 0
Australia
Phone 39599 0
+61731762111
Fax 39599 0
Email 39599 0
l.marney@gmail.com
Contact person for scientific queries
Name 39600 0
Dr Lucy Marney
Address 39600 0
Dept of Cardiothoracic Surgery
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba QLD 4102
Country 39600 0
Australia
Phone 39600 0
+61731762111
Fax 39600 0
Email 39600 0
l.marney@gmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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