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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000497707
Acronym
Nil
Enrollment
200
Registered
2013-05-06
Start date
2013-06-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 s

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.

Sponsors

Australian and New Zealand Society of Cardiac and Thoracic Surgeons
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
30 Years to 75 Years
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026