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

Effects of Very Low Calorie Diet vs Metabolic Surgery on Weight Loss and Obesity Comorbidities: a Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; Obesity, Morbid; Bariatric Surgery Candidate; Diet, Healthy
• Intervention / Treatment: Behavioral: Very low calorie diet with Fortimel (Nutricia) supplementation; Procedure: Metabolic Surgery

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 Type: Interventional
• Enrollment (Actual): 218
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00168
    • Catholic University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intensive lifestyle modification: Very low calorie diet; Patients will undergo a very low calorie diet	Behavioral: Very low calorie diet with Fortimel (Nutricia) supplementation; Patients will undergo a very low calorie diet
Active Comparator: Metabolic Surgery; Patients will undergo metabolic surgery	Procedure: Metabolic Surgery; Patients will undergo metabolic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to achieve a 25% reduction in Body Mass Index	1-12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of participants who achieve 25% reduction in Body Mass Index	1-12 months
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
Change in insulin resistance (assessed by HOMA-IR), from baseline, at 12 and 24 months follow up	1-24months
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

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2020
• Primary Completion (Actual): December 28, 2020
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: September 30, 2020
• First Submitted That Met QC Criteria: October 6, 2020
• First Posted (Actual): October 12, 2020

Study Record Updates

• Last Update Posted (Actual): May 25, 2021
• Last Update Submitted That Met QC Criteria: May 23, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Obesity; Weight Loss; Obesity, Morbid
• Other Study ID Numbers: 20203009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No