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

Primary Purpose

Obesity, Morbid, Obesity, Diet, Healthy

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Very low calorie diet with Fortimel (Nutricia) supplementation
Metabolic Surgery
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Morbid

Eligibility Criteria

19 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Catholic University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intensive lifestyle modification: Very low calorie diet

Metabolic Surgery

Arm Description

Patients will undergo a very low calorie diet

Patients will undergo metabolic surgery

Outcomes

Primary Outcome Measures

Time to achieve a 25% reduction in Body Mass Index

Secondary Outcome Measures

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

Full Information

First Posted
September 30, 2020
Last Updated
May 23, 2021
Sponsor
Catholic University of the Sacred Heart
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1. Study Identification

Unique Protocol Identification Number
NCT04583683
Brief Title
Effects of Very Low Calorie Diet vs Metabolic Surgery on Weight Loss and Obesity Comorbidities
Acronym
ARGOS
Official Title
Effects of Very Low Calorie Diet vs Metabolic Surgery on Weight Loss and Obesity Comorbidities: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 30, 2020 (Actual)
Primary Completion Date
December 28, 2020 (Actual)
Study Completion Date
September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid, Obesity, Diet, Healthy, Bariatric Surgery Candidate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
218 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intensive lifestyle modification: Very low calorie diet
Arm Type
Active Comparator
Arm Description
Patients will undergo a very low calorie diet
Arm Title
Metabolic Surgery
Arm Type
Active Comparator
Arm Description
Patients will undergo metabolic surgery
Intervention Type
Behavioral
Intervention Name(s)
Very low calorie diet with Fortimel (Nutricia) supplementation
Intervention Description
Patients will undergo a very low calorie diet
Intervention Type
Procedure
Intervention Name(s)
Metabolic Surgery
Intervention Description
Patients will undergo metabolic surgery
Primary Outcome Measure Information:
Title
Time to achieve a 25% reduction in Body Mass Index
Time Frame
1-12 months
Secondary Outcome Measure Information:
Title
Percentage of participants who achieve 25% reduction in Body Mass Index
Time Frame
1-12 months
Title
Time to achieve 25% reduction in Body Mass Index
Time Frame
1-24months
Title
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
Time Frame
1-24months
Title
Change in glycated hemoglobin (HbA1c), from baseline, at 12 and 24 months follow up (patients with diabetes)
Time Frame
1-24months
Title
Change in fasting glucose and fasting insulin, from baseline, at 12 and 24 months follow up
Time Frame
1-24months
Title
Change in insulin resistance (assessed by HOMA-IR), from baseline, at 12 and 24 months follow up
Time Frame
1-24months
Title
Change in blood pressure, from baseline, at 12 and 24 months follow up
Time Frame
1-24months
Title
Change in total, HDL, LDL and total cholesterol from baseline, at 12 and 24 months follow up
Time Frame
1-24months
Title
Change in triglycerides from baseline, at 12 and 24 months follow up
Time Frame
1-24months
Title
Percentage of participants who maintain weight loss at 24 months follow up
Time Frame
1-24months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Catholic University School of Medicine
City
Rome
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

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

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