An interventional study of Very low calorie diet with Fortimel (Nutricia) supplementation and Metabolic Surgery in Obesity, Morbid, Obesity and Diet, Healthy, sponsored by Catholic University of the Sacred Heart. Status unknown at 1 site in Italy. Open to participants aged 19 Years to 69 Years. Per ClinicalTrials.gov, last updated 2021-05-25.
Sponsored by Catholic University of the Sacred Heart · Not applicable, Interventional, and Treatment
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 218 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Catholic University of the Sacred Heart is the lead sponsor of 227 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will undergo a very low calorie diet
Behavioral: Very low calorie diet with Fortimel (Nutricia) supplementation
Patients will undergo metabolic surgery
Procedure: Metabolic Surgery
Patients will undergo a very low calorie diet
Patients will undergo metabolic surgery
Time to achieve a 25% reduction in Body Mass Index
Time frame: 1-12 months
Percentage of participants who achieve 25% reduction in Body Mass Index
Time frame: 1-12 months
Time to achieve 25% reduction in Body Mass Index
Time frame: 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
Time frame: 1-24months
Change in glycated hemoglobin (HbA1c), from baseline, at 12 and 24 months follow up (patients with diabetes)
Time frame: 1-24months
Change in fasting glucose and fasting insulin, from baseline, at 12 and 24 months follow up
Time frame: 1-24months
Change in insulin resistance (assessed by HOMA-IR), from baseline, at 12 and 24 months follow up
Time frame: 1-24months
Change in blood pressure, from baseline, at 12 and 24 months follow up
Time frame: 1-24months
Change in total, HDL, LDL and total cholesterol from baseline, at 12 and 24 months follow up
Time frame: 1-24months
Change in triglycerides from baseline, at 12 and 24 months follow up
Time frame: 1-24months
Percentage of participants who maintain weight loss at 24 months follow up
Time frame: 1-24months
This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Catholic University of the Sacred Heart