Effects of Very Low Calorie Diet vs Metabolic Surgery on Weight Loss and Obesity Comorbidities

Not Applicable

• Conditions: Obesity; Obesity, Morbid; Diet, Healthy; Bariatric Surgery Candidate
• Interventions: Procedure: Metabolic Surgery; Behavioral: Very low calorie diet with Fortimel (Nutricia) supplementation

• Registration Number: NCT04583683
• Lead Sponsor: Catholic University of the Sacred Heart

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.

Study Timeline

• Study Start: 2020-09-30
• Study First Submitted: 2020-09-30
• Study First Submitted QC: 2020-10-06
• Study First Posted: 2020-10-12
• Primary Completion: 2020-12-28
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-23
• Last Update Posted: 2021-05-25
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 218

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metabolic Surgery	Metabolic Surgery	Patients will undergo metabolic surgery
Intensive lifestyle modification: Very low calorie diet	Very low calorie diet with Fortimel (Nutricia) supplementation	Patients will undergo a very low calorie diet

Primary Outcome Measures

Name	Time	Method
Time to achieve a 25% reduction in Body Mass Index	1-12 months

Secondary Outcome Measures

Name	Time	Method
Time to achieve 25% reduction in Body Mass Index	1-24months
Change in blood pressure, 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
Percentage of participants who achieve 25% reduction in Body Mass Index	1-12 months
Change in total, HDL, LDL and total cholesterol from baseline, at 12 and 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 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 fasting glucose and fasting insulin, from baseline, at 12 and 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

Trial Locations

Locations (1)

Catholic University School of Medicine; 🇮🇹 Rome, Italy