Very low calorie diet in cardiac surgery patients with obesity and metabolic syndrome: short and mid-term outcomes

Not Applicable

• Conditions: Elective cardiac surgery; Obesity; Metabolic syndrome; Diet and Nutrition - Obesity; Surgery - Other surgery; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12613000497707
• Lead Sponsor: Australian and New Zealand Society of Cardiac and Thoracic Surgeons

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Elective cardiac surgery patients
Aged 30-75 years
Obese (WHO BMI criteria, waist measurements)
Metabolic syndrome (modified NCEP-ATP III criteria)

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight change (kg)<br><br>Examples<br>- weight at recruitment minus weight following completion of VLCD OR <br>- weight at recruitment minus weight at follow-up (6 and 12 months post-operatively)<br>[At recruitment<br>After completion of VLCD<br>At follow-up (6 and 12 months post-operatively)];30 day morbidity, including:<br>- Major Adverse Cardiac or Cerebrovascular Events (MACE) including myocardial infarction, stroke, need for revascularisation<br>- New arrhythmia, pacemaker insertion<br>- Respiratory complication (e.g. prolonged intubation, pneumonia, pleural effusion/pneumothorax)<br>- Sepsis<br>- Wound complications<br>- Venous thromboembolism <br><br>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[Within 30 days of surgery];30 day mortality[Within 30 days of surgery]