E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients affected by type 2 diabetes and non alcoholic fatty liver disease- non alcoholic steato-hepatitis (NAFLD/NASH) |
Pazienti affetti da diabete di tipo 2 e steatosi-steatoepatite non alcool-correlata (NAFLD/NASH) |
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E.1.1.1 | Medical condition in easily understood language |
Patients affected by type 2 diabetes and non alcoholic fatty liver disease- non alcoholic steato-hepatitis (NAFLD/NASH) |
Pazienti affetti da diabete di tipo 2 e steatosi-steatoepatite non alcool-correlata (NAFLD/NASH) |
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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 | SOC |
E.1.2 | Classification code | 10027433 |
E.1.2 | Term | Metabolism and nutrition disorders |
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 |
To evaluate the efficacy of oral supplementation with cholecalciferol in improving liver steato-inflammation in patients with type 2 diabetes mellitus and diagnosis of NAFLD or NASH. |
Valutare l’efficacia della supplementazione orale con colecalciferolo nel migliorare la steato-infiammazione epatica in pazienti con diabete mellito di tipo 2 e diagnosi di NAFLD o NASH. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the efficacy of oral supplementation with cholecalciferol in improving cardio-metabolic risk profile (insulin-sensitivity, lipids, sistemic inflammation, glucose tolerance, body fat distribution) in patients with type 2 diabetes mellitus and diagnosis of NAFLD or NASH. |
Valutare l’efficacia della supplementazione orale con colecalciferolo nel migliorare il profilo di rischio cardio-metabolico (sensibilità insulinica, assetto lipidico, markers di infiammazione sistemica, tolleranza glucidica, distribuzione del grasso corporeo)in pazienti con diabete mellito di tipo 2 e diagnosi di NAFLD o NASH. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Aged between 25 and 65 years
Diagnosis of Type 2 Diabetes Mellitus
Presence of ultrasound detected fatty liver confirmed by MRI
acceptance of informed consent |
Età compresa tra 25 e 65 anni
Diagnosi di Diabete Mellito di tipo 2
Presenza di steatosi epatica rilevata alla ecografia epatica e confermata dall’esecuzione di RMN
Accettazione consapevole del consenso informato |
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E.4 | Principal exclusion criteria |
e <25 or> 65 years
History of alcohol abuse (> 40 mg / day for men,> 20 mg / day for women)
Acute or chronic liver infections autoimmune hepatitis
History of cancer
Other causes of liver disease (hemochromatosis, Wilson's disease)
renal failure
Hyper / hypoparathyroidism
chronic enteropathies
Hypersensitivity to any of the excipients or cholecalciferol hypercalcemia, hypercalciuria (nephrolithiasis, nephrocalcinosis) Therapy with vitamin D, calcium or other drugs affecting bone metabolism, calcium and vitamin D metabolism (anticonvulsants, glucocorticoids, antacids containing aluminum, cholestyramine ) Pregnancy and lactation |
Età < 25 anni o > 65 anni
Storia di abuso alcolico (>40 mg/die per l’uomo, >20 mg/die per la donna)
Infezioni epatiche croniche o acute in atto
Epatite autoimmune
Storia di neoplasie
Altre cause di epatopatie (Emocromatosi, Morbo di Wilson)
Insufficienza renale
Iper/ipoparatiroidismo
Enteropatie croniche
Ipersensibilità al colecalciferolo o a uno qualsiasi degli eccipienti Ipercalcemia, ipercalciuria Calcolosi renale (nefrolitiasi, nefrocalcinosi) Terapia con vitamina D, calcio o altri farmaci che influenzino il metabolismo osteo-calcico e il metabolismo della vitamina D (anticonvulsivanti, glucocorticoidi, antiacidi contenenti alluminio, colestiramina) Gravidanza e allattamento |
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E.5 End points |
E.5.1 | Primary end point(s) |
Reduction of hepatic steatosis in patients with NAFLD and reduction in steatosis, inflammation and liver fibrosis in patients with NASH treated with Vitamin D oral supplementation |
Riduzione della steatosi epatica nei soggetti affetti da NAFLD e riduzione della steatosi, dell’infiammazione e della fibrosi epatica nei soggetti affetti da NASH dopo trattamento con supplementazione orale di vitamina D |
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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) |
The secondary objective of this study is to assess changes in the cardio-metabolic risk profile in diabetic patients treated with Vitamin D oral supplementation |
L’obiettivo secondario dello studio è valutare le modificazioni del profilo di rischio cardio-metabolico |
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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 | Yes |
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 | 18 |
E.8.9.1 | In the Member State concerned days | 0 |