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

NCT ID: NCT04583683

Last Updated: 2021-05-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 218 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2022-09-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intensive lifestyle modification: Very low calorie diet

Patients will undergo a very low calorie diet

Group Type: ACTIVE_COMPARATOR

Very low calorie diet with Fortimel (Nutricia) supplementation

Intervention Type: BEHAVIORAL

Patients will undergo a very low calorie diet

Metabolic Surgery

Patients will undergo metabolic surgery

Group Type: ACTIVE_COMPARATOR

Metabolic Surgery

Intervention Type: PROCEDURE

Patients will undergo metabolic surgery

Interventions

Very low calorie diet with Fortimel (Nutricia) supplementation

Patients will undergo a very low calorie diet

Intervention Type: BEHAVIORAL

Metabolic Surgery

Patients will undergo metabolic surgery

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catholic University of the Sacred Heart

OTHER

Sponsor Role: lead

Responsible Party

Geltrude Mingrone

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Catholic University School of Medicine

Rome, , Italy

Countries

Italy

Other Identifiers

20203009

Identifier Type: -

Identifier Source: org_study_id