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This is an open label study in which obese participants were treated with a restrictive hypo-caloric diet under hospitalization for a maximum period of 3 months in a metabolic rehabilitation unit. A multidisciplinary approach was used (combination of diet, physical exercise and psychotherapy)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Experimental | Obese subjects with BMI >= 30 and with one or more of metabolic comorbidities (type 2 diabetes mellitus, dyslipidemia, high blood pressure, hyperuricemia, and others). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multidisciplinary treatment of obesity (diet + vitamin D + exercise + psychotherapy) | Other | Body weight reduction was induced by a low-energy mixed diet (55 % carbohydrates, 30 % lipids and 15 % proteins) providing 600 kcal less than individually estimated energy requirements based on the measured REE. The energy content and macronutrient composition of the diets adhered to the nutritional recommendations of the American Diabetes Association. Patients were administered vitamin D supplement only if they presented a value of 25-hydroxyvitamin D (25OHD) <30 ng/ml in blood tests at the beginning. Patients were following an individualized physical activity plan within the hospital and were aided by a psychodynamic approach therapist. |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | Change in body Weight | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| GlycaemIa | Change in glycaemia | 12 weeks |
| Insulin | Change in insulin blood levels | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body composition - Body Fat Mass | Change in Body Fat | 12 weeks |
| Body composition - Body Fat free mass | change in Body Fat free mass | 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mariangela Rondanelli, MD, PhD | Azienda di Servizi alla Persona di Pavia | Study Director |
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IPD are not shared. Published article will display mean baseline values and mean differences from baseline.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| D014807 | Vitamin D |
| D015444 | Exercise |
| D011613 | Psychotherapy |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D012632 | Secosteroids |
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Open Label study
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|
| Homa IR | Change in HOMA-IR | 12 weeks |
| Total cholesterol | Change in blood total cholesterol | 12 weeks |
| LDL cholesterol | Change in LDL cholesterol | 12 weeks |
| HDL cholesterol | Change in HDL cholesterol | 12 weeks |
| Triglycerides | Change in triglycerides | 12 weeks |
| AST (Aspartate Aminotransferase) | Change in blood of Aspartate Aminotransferase (AST) | 12 weeks |
| ALT (alanine aminotransferase) | Change in blood of alanine aminotransferase (ALT) | 12 weeks |
| GGT (gamma-glutamyl transpeptidase) | Change in blood of gamma-glutamyl transpeptidase (GGT) | 12 weeks |
| Total bilirubin | Change in blood total bilirubin | 12 weeks |
| Basal metabolic rate | Change in basal metabolic rate | 12 weeks |
| Body composition - Visceral Fat mass | change in Visceral Fat mass | 12 weeks |
| Body Circumferences - arm | change in circumferences (arm) | 12 weeks |
| Body Circumferences - calf | change in circumferences (calf) | 12 weeks |
| Body Circumferences - waist | change in circumferences ( waist) | 12 weeks |
| Body Circumferences - hips | change in circumferences (hips) | 12 weeks |
| Iron | Change in blood Iron concentration | 12 weeks |
| Other biochemical parameters - vit D | Change in blood vitamin D | 12 weeks |
| Other biochemical parameters - vit B12 | Change in blood vitamin B12 | 12 weeks |
| Other biochemical parameters - Folates | Change in blood Folates | 12 weeks |
| Other biochemical parameters - transferrin | Change in transferrin | 12 weeks |
| Other biochemical parameters - Homocystein | Change in Homocystein | 12 weeks |
| Other biochemical parameters - albumin | Change in blood proteins (albumin) | 12 weeks |
| Other biochemical parameters - prealbumin | Change in blood proteins (prealbumin) | 12 weeks |
| Other biochemical parameters - enzymes - lipase | Change in blood enzymes (lipase) | 12 weeks |
| Other biochemical parameters - enzymes - amylase | Change in blood enzymes (amylase) | 12 weeks |
| Other biochemical parameters - thyroid hormones - FT3 | Change in FT3 | 12 weeks |
| Other biochemical parameters - thyroid hormones - FT4 | Change in FT4 | 12 weeks |
| Other biochemical parameters - thyroid hormones - TSH | Change in TSH | 12 weeks |
| Other biochemical parameters - inflammatory markers - CRP | Change in C-reactive protein | 12 weeks |
| Other biochemical parameters - inflammatory markers - ESR | Change in Erythrocyte Sedimentation Rate | 12 weeks |
| Other biochemical parameters - creatinin | Change in blood creatinin | 12 weeks |
| Uric acid | Change in uric acid blood concentration | 12 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D004191 | Behavioral Disciplines and Activities |