Bariatric Surgery Candidate, Diet, Healthy, Obesity, Obesity, Morbid
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALVery low calorie diet with Fortimel (Nutricia) supplementation
Patients will undergo a very low calorie diet
PROCEDUREMetabolic Surgery
Patients will undergo metabolic surgery
Sponsors
Catholic University of the Sacred Heart
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 69 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to achieve a 25% reduction in Body Mass Index | 1-12 months |
Secondary
| Measure | Time frame |
|---|---|
| Time to achieve 25% reduction in Body Mass Index | 1-24months |
| Change in body composition (lean mass-all tissues in the body except bone and fat-fat mass, bone density and visceral fat) using dual energy X-ray absorptiometry (DXA), from baseline, at 25% weight loss, at 12 months follow up and at 24 months follow up | 1-24months |
| Change in glycated hemoglobin (HbA1c), from baseline, at 12 and 24 months follow up (patients with diabetes) | 1-24months |
| Change in fasting glucose and fasting insulin, from baseline, at 12 and 24 months follow up | 1-24months |
| Percentage of participants who achieve 25% reduction in Body Mass Index | 1-12 months |
| Change in blood pressure, from baseline, at 12 and 24 months follow up | 1-24months |
| Change in total, HDL, LDL and total cholesterol from baseline, at 12 and 24 months follow up | 1-24months |
| Change in triglycerides from baseline, at 12 and 24 months follow up | 1-24months |
| Percentage of participants who maintain weight loss at 24 months follow up | 1-24months |
| Change in insulin resistance (assessed by HOMA-IR), from baseline, at 12 and 24 months follow up | 1-24months |
Countries
Italy
Outcome results
None listed