Effects of Very Low Calorie Diet vs Metabolic Surgery on Weight Loss and Obesity Comorbidities
Effects of Very Low Calorie Diet vs Metabolic Surgery on Weight Loss and Obesity Comorbidities
It is a prospective randomized trial on 218 subjects, 109 for each arms. The purpose of this
 trial is to compare very low calorie diet and metabolic surgery induced weight loss and its
 maintenance.
Obesity is a leading public health issued associated with poor quality of life, morbidity and
 an increased mortality rate. Although metabolic surgery results in a greater weight loss when
 compared to non-surgical approaches, a low calorie diet associated with intensive maintenance
 session may be a valid alternative for weight loss. Since lifestyle interventions are safer
 and potentially more cost effective than metabolic surgery, this trial will test whether an
 intensive lifestyle intervention is as effective as metabolic surgery to induce weight loss
 and its maintenance.

 A total of 218 participants will be randomly assigned to metabolic surgery (109) or intensive
 lifestyle intervention (109).

 Clinical outcomes will be assessed at 25% reduction in Body Mass Index (BMI), at 12 months
 and 24 months.
Inclusion Criteria:

 -  Aged between 19 and 69 years

 -  Body Mass Index ≥35 kg/m2 and at least one or more obesity-related co-morbidities such
 as type II diabetes (T2DM), hypertension, sleep apnea and other respiratory disorders,
 non-alcoholic fatty liver disease, osteoarthritis, lipid abnormalities,
 gastrointestinal disorders, or heart disease

 -  Body Mass Index ≥40 kg/m2

 Exclusion Criteria:

 -  Pregnancy

 -  Active cancer

 -  End stage renal failure

 -  End stage liver failure

 -  Being unable to understand and sign informed consent