Obesity
Conditions
Brief summary
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)
Interventions
OTHERMultidisciplinary treatment of obesity (diet + vitamin D + exercise + psychotherapy)
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.
Sponsors
Azienda di Servizi alla Persona di Pavia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open Label study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age \>= 18 * BMI \>= 30 * one or more comorbidities (type 2 diabetes mellitus, dyslipidemia, high blood pressure, hyperuricemia, and others)
Exclusion criteria
* active cancer * severe cognitive or functional impairments * severe behavioral disorders * known kidney failure (previous glomerular filtration rate \<30 ml/min) * known liver failure (Child B or C)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight | 12 weeks | Change in body Weight |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin | 12 weeks | Change in insulin blood levels |
| Homa IR | 12 weeks | Change in HOMA-IR |
| Total cholesterol | 12 weeks | Change in blood total cholesterol |
| LDL cholesterol | 12 weeks | Change in LDL cholesterol |
| HDL cholesterol | 12 weeks | Change in HDL cholesterol |
| GlycaemIa | 12 weeks | Change in glycaemia |
| AST (Aspartate Aminotransferase) | 12 weeks | Change in blood of Aspartate Aminotransferase (AST) |
| ALT (alanine aminotransferase) | 12 weeks | Change in blood of alanine aminotransferase (ALT) |
| GGT (gamma-glutamyl transpeptidase) | 12 weeks | Change in blood of gamma-glutamyl transpeptidase (GGT) |
| Total bilirubin | 12 weeks | Change in blood total bilirubin |
| Basal metabolic rate | 12 weeks | Change in basal metabolic rate |
| Triglycerides | 12 weeks | Change in triglycerides |
Other
| Measure | Time frame | Description |
|---|---|---|
| Other biochemical parameters - albumin | 12 weeks | Change in blood proteins (albumin) |
| Other biochemical parameters - prealbumin | 12 weeks | Change in blood proteins (prealbumin) |
| Other biochemical parameters - enzymes - lipase | 12 weeks | Change in blood enzymes (lipase) |
| Other biochemical parameters - enzymes - amylase | 12 weeks | Change in blood enzymes (amylase) |
| Other biochemical parameters - thyroid hormones - FT3 | 12 weeks | Change in FT3 |
| Body composition - Body Fat Mass | 12 weeks | Change in Body Fat |
| Other biochemical parameters - thyroid hormones - TSH | 12 weeks | Change in TSH |
| Other biochemical parameters - inflammatory markers - CRP | 12 weeks | Change in C-reactive protein |
| Other biochemical parameters - inflammatory markers - ESR | 12 weeks | Change in Erythrocyte Sedimentation Rate |
| Other biochemical parameters - creatinin | 12 weeks | Change in blood creatinin |
| Uric acid | 12 weeks | Change in uric acid blood concentration |
| Other biochemical parameters - thyroid hormones - FT4 | 12 weeks | Change in FT4 |
| Body composition - Body Fat free mass | 12 weeks | change in Body Fat free mass |
| Body composition - Visceral Fat mass | 12 weeks | change in Visceral Fat mass |
| Body Circumferences - arm | 12 weeks | change in circumferences (arm) |
| Body Circumferences - calf | 12 weeks | change in circumferences (calf) |
| Body Circumferences - waist | 12 weeks | change in circumferences ( waist) |
| Body Circumferences - hips | 12 weeks | change in circumferences (hips) |
| Iron | 12 weeks | Change in blood Iron concentration |
| Other biochemical parameters - vit D | 12 weeks | Change in blood vitamin D |
| Other biochemical parameters - vit B12 | 12 weeks | Change in blood vitamin B12 |
| Other biochemical parameters - Folates | 12 weeks | Change in blood Folates |
| Other biochemical parameters - transferrin | 12 weeks | Change in transferrin |
| Other biochemical parameters - Homocystein | 12 weeks | Change in Homocystein |
Outcome results
None listed