ARGOS: Effects of Very Low Calorie Diet vs Metabolic Surgery on Weight Loss and Obesity Comorbidities
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Time to achieve a 25% reduction in Body Mass Index [1-12 months]
Secondary Outcome Measures
- 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]
Eligibility Criteria
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
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Body Mass Index ≥40 kg/m2
Exclusion Criteria:
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Pregnancy
-
Active cancer
-
End stage renal failure
-
End stage liver failure
-
Being unable to understand and sign informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Catholic University School of Medicine | Rome | Italy | 00168 |
Sponsors and Collaborators
- Catholic University of the Sacred Heart
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20203009