E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10029883 |
E.1.2 | Term | Obesity |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
valutare se la restrizione calorica di per sé possa essere sufficiente a ripristinare valori di vitamina D nel range di normalità e se un migliore apporto di vitamina D nella dieta possa contribuire a migliorare il profilo cardiometabolico nell’obesità, oltre alla restrizione calorica. |
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E.2.2 | Secondary objectives of the trial |
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. |
Il secondo punto fondamentale è quello di riuscire a comprendere se la supplementazione con vitamina D possa andare a rafforzare gli effetti benefici conseguenti alla restrizione calorica e qualora così dovesse verificarsi, individuare su quali parametri la vitamina D agisce in maniera preponderante e ipotizzare i meccanismi patogenetici retrostanti |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
obese subjects aged ≥18 and ≤70 years |
età compresa tra 18 e 70 anni, maschi e femmine, obesi |
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E.4 | Principal 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, β -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. |
diagnosi nota di diabete assunzione di farmaci contenente vit. D o calcio |
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E.5 End points |
E.5.1 | 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. |
valutare gli effetti della Vit. D sull'insulinosensibilità valutati mediante indici indiretti e diretti |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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) |
valutazione del profilo cardiovascolare |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |