Obesity MedDRA version: 14.1 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: DIBASE*OS SOLUZ 2,5ML 25000UI
Pharmaceutical Form: Oral drops
INN or Proposed INN: CHOLECALCIFEROL CONCENTRATE (WATER-DISPERSIBLE FORM)
Concentration unit: U/ml unit(s)/millilitre
Concentr
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: obese subjects aged =18 and =70 years Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1:fasting plasma glucose = 126 mg/ or who report themselves to have diabetes or who take any oral glucose-lowering medication or insulin 2: resting BP > 140/90 mmHg or those who reported themselves to be hypertensive or those on any antihypertensive medication; 3: cholecalciferol or calcium supplementation in last 6 months; 4:chronic renal, hepatic, malignant or intestinal disease (self reported o r any suggestive medical documents) or renal stones; 5:any medication within the last month that could influence insulin secretion, insulin sensitivity, vitamin D or calcium metabolism (e.g. theophylline, phenytoin, ß -blockers, diuretics, statins or renin–angiotensina system inhibitors, etc.); 6:febrile illness or infective morbidity in the last 10 days; and 7:grossly deranged liver (serum bilirubin > 34 µmol/l and serum glutamic pyruvic transaminase more than four times upper limit of normal) or kidney function (serum creatinine male =1.4 mg/dL (124 µmol/L); female =1.3 mg/dL (115 µmol/L). 8: heart disease and lung 9: primary and secondary hyperparathyroidism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objective is to be able to understand if supplementation with vitamin D may be to enhance the beneficial effects resulting from the caloric restriction and when it does occur, to identify which parameters of vitamin D acts predominantly and to suggest pathogenic mechanisms behind.;Primary end point(s): The primary endpoint is to evaluate the effects of vitamin D on insulinsensitivity evaluated by Hepatic fasting insulin sensitivity [homeostasis model assessment (HOMA), quantitative insulinsensitivity check index, HOMA-2], postprandial insulin sensitivity [oral glucose insulin sensitivity (OGIS)], insulin secretion (HOMA%B, HOMA2-%B) derived by oral glucose tolerance and insulin sensitivity evaluated by hyperinsulinemic euglycemic clamp.;Timepoint(s) of evaluation of this end point: 6 months;Main Objective: The purpose of this study is to evaluate whether caloric restriction in itself may be sufficient to restore the values of vitamin D in the normal range and if a further supplementation of vitamin D along with the diet can contribute to improve the cardiometabolic profile in obesity | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcome measures are: blood pressure, lipid profile, assessing body composition by DEXA, evaluation phospho-calcic metabolism (PTH, vitamin D, calcium); evaluation pattern of inflammation (IL6, IL10, adiponectin, TNF, C-reactive protein, fibrinogen), coagulation parameters of evaluation (analysis 3, lysis area, maximum absorbance capacity);Timepoint(s) of evaluation of this end point: 6 months | — |
Countries
Italy
Contacts
Public ContactEndocr. e malattie del ricambio
Policlinico Gemelli
Outcome results
None listed