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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive lifestyle modification: Very low calorie diet | Active Comparator | Patients will undergo a very low calorie diet |
|
| Metabolic Surgery | Active Comparator | Patients will undergo metabolic surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Very low calorie diet with Fortimel (Nutricia) supplementation | Behavioral | Patients will undergo a very low calorie diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to achieve a 25% reduction in Body Mass Index | 1-12 months |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic University School of Medicine | Rome | 00168 | Italy |
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| Metabolic Surgery | Procedure | Patients will undergo metabolic surgery |
|
| 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 |
| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D050110 | Bariatric Surgery |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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