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

Obesity Clinical Trial

— ARGOS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04583683
• Other study ID #: 20203009
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 30, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: May 2021
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 218
• Est. completion date: September 30, 2022
• Est. primary completion date: December 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Italy	Catholic University School of Medicine	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to achieve a 25% reduction in Body Mass Index		1-12 months
Secondary	Percentage of participants who achieve 25% reduction in Body Mass Index		1-12 months
Secondary	Time to achieve 25% reduction in Body Mass Index		1-24months
Secondary	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
Secondary	Change in glycated hemoglobin (HbA1c), from baseline, at 12 and 24 months follow up (patients with diabetes)		1-24months
Secondary	Change in fasting glucose and fasting insulin, from baseline, at 12 and 24 months follow up		1-24months
Secondary	Change in insulin resistance (assessed by HOMA-IR), from baseline, at 12 and 24 months follow up		1-24months
Secondary	Change in blood pressure, from baseline, at 12 and 24 months follow up		1-24months
Secondary	Change in total, HDL, LDL and total cholesterol from baseline, at 12 and 24 months follow up		1-24months
Secondary	Change in triglycerides from baseline, at 12 and 24 months follow up		1-24months
Secondary	Percentage of participants who maintain weight loss at 24 months follow up		1-24months