NCT04583683

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: a Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 218 (actual)
• Sponsor: Catholic University of the Sacred Heart · Academic / Other
• Sex: All
• Age: 19 Years – 69 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity, Morbid
• Obesity
• Diet, Healthy
• Bariatric Surgery Candidate

Interventions

Type	Name	Description
BEHAVIORAL	Very low calorie diet with Fortimel (Nutricia) supplementation	Patients will undergo a very low calorie diet
PROCEDURE	Metabolic Surgery	Patients will undergo metabolic surgery

Timeline

• Start date: 2020-09-30
• Primary completion: 2020-12-28
• Completion: 2022-09-30
• First posted: 2020-10-12
• Last updated: 2021-05-25

Locations

1 site across 1 country: Italy