The Department of Experimental Medicine stands out as one of the most active in designing, conducting, and implementing spontaneous, non-profit clinical trials, particularly regarding the study of orphan molecules and rare diseases.
Clinical research suffers from a chronic shortage of funding; consequently, the majority of clinical studies are designed and conducted by pharmaceutical companies, with the limitations that this may entail.
Spontaneous clinical trials represent the most significant means by which clinicians strive to address unresolved issues and unmet needs for patients.
We gratefully acknowledge many patients refering to our facility who voluntarily participate in clinical trials. It is because of them that the advancement of science through these clinical research is possible. Our heartfelt gratitude goes to each of them.
| TITOLO | CLINICAL TRIAL.GOV ID | RESPONSABILE | STATUS |
|---|---|---|---|
| Rediscovering Biomarkers for the Diagnosis and Early Treatment Response in NEN (REBORN) | NCT04464122 | Andrea Isidori | Recruiting |
| Changes in the Hypotalamic-pituitary Region of Patients With Metabolic Syndrome and Obesity | NCT03458533 | Andrea Isidori | Completed |
| Endocrine Cardiomyopathy: Response to Cyclic GMP PDE5 Inhibitors in Acromegaly Cardiomyopathy | NCT02611336 | Andrea Isidori | Completed |
| Endocrine Cardiomyopathy in Cushing Syndrome: Response to Cyclic GMP PDE5 inhibitOrs | NCT02611258 | Andrea Isidori | Completed |
| PRecisiOn MEdicine to Target Frailty of Endocrine-metabolic Origin | NCT04856683 | Andrea Isidori | Recruiting |
| Clinical Study on Circadian Genes Dysregulation in Patients With Glucocorticoid Disorders | NCT04374721 | Andrea Isidori | Recruiting |
| PegvisOMant and the Immune SystEm (PROMISE) | NCT05069324 | Andrea Isidori | Completed |
| The Circadian Rhythm in CusHing SyndrOme in Active Phase and dUring RemiSsion (TheHOURS) | NCT03343470 | Andrea Isidori | Completed |
| Impact of Adrenal IncidenTalomas and Possible Autonomous Cortisol Secretion on Cardiovascular and Metabolic Alterations (ITACA) | NCT04127552 | Andrea Isidori | Active |
| Thyroid Function and Structure IN Klinefelter Syndrome (THINKS) | NCT05581147 | Andrea Isidori | Recruiting |
| Evaluation of iMmune Function in Post-surgical and AuToimmune HYpoparathyroidism (EMPATHY) | NCT04059380 | Andrea Isidori | Recruiting |
| Studio Gonadis - Status gonadico in disordini ipofisari e surrenalici | Andrea Isidori | Recruiting | |
| Impatto dei contraccettivi orali sulla funzione sessuale, composizione corporea e metabolismo osseo in una coorte di donne italiane: studio ORION | Andrea Isidori | Recruiting | |
| Deficit ipofisario post-chirurgico: ruolo predittivo di un’analisi innovativa delle sequenze di Risonanza Magnetica pre-operatoria | Andrea Isidori | Completed | |
| Qualità di vita e funzione sessuale in pazienti affetti da neoplasie neuroendocrine | Elisa Giannetta | Recruiting | |
| Studio SoNAR-Global – nuove vulnerabilità legate al COVID-19 | Daniele Gianfrilli | Completed | |
| Ruolo diagnostico e prognostico della RM-DWI nelle neoplasie neuroendocrine a confronto con l’imaging funzionale | Elisa Giannetta | Recruiting | |
| Valutazione dell'asse ipotalamo-ipofisi-testicolo, composizione corporea e funzione sessuale in soggetti con infezione cronica da HCV sottoposti a eradicazione con agenti antivirali diretti di seconda generazione | Andrea Isidori | Active | |
| Valutazione degli effetti dell'asse somatotropo sullo sviluppo testicolare | Daniele Gianfrilli | Recruiting | |
| Valutazione degli effetti molecolari, endocrini, genotossici e transgenerazionali dell'inquinamento ambientale su sviluppo, riproduzione e salute sessuale maschile | Andrea Isidori | Recruiting | |
| Protocol ITANET - Registry | NCT04282083 | Andrea Isidori | Recruiting |
| A European Post-Authorisation Observational Study (Registry) of Patients With Chronic Adrenal Insufficiency (AI) (EU-AIR) | NCT01661387 | Andrea Isidori | Completed |
| A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome (GRACE) | NCT03697109 | Andrea Isidori | Active |
| Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal Adenomas (GRADIENT) | NCT04308590 | Andrea Isidori | Active |
| A Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone Deficiency (foresiGHt) | NCT04615273 | Andrea Isidori | Active |
| CAHtalyst - Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia | NCT04490915 | Andrea Isidori | Active |
| The GROWEDA study: GROwth hormone deficiency - a comparison between WEekly and DAily somatropin therapy during adolescence | Andrea Isidori | Recruiting | |
| Dalla sindrome di Klinefelter alle aneuploidie maggiori dei cromosomi sessuali con fenotipo maschile: ricerca di un effetto dose dei cromosomi X aggiuntivi sui parametri clinici, ormonali, metabolici ed ecocardiografici | Andrea Isidori | Recruiting | |
| A Study of Oral Ladarixin in Recent Onset Type 1 Diabetes and a Low Residual β-cell Function | NCT04628481 | Raffaella Buzzetti | Recruiting |
| A Study to Assess Efficacy/Safety of Ladarixin in Type 1 Diabetes Patients With Preserved ß-cell Function at Baseline. | NCT04899271 | Raffaella Buzzetti | Active |
| A Research Study Looking at Long-term Blood Sugar Control in People With Type 2 Diabetes Being Treated With Xultophy® in a Real-world Setting in Italy (studio REX) | NCT04666987 | Raffaella Buzzetti | Completed |
| A Research Study to Compare Two Types of Insulin, a New Weekly Insulin, Insulin Icodec and an Available Daily Insulin, Insulin Glargine, Both in Combination With Mealtime Insulin, in People With Type 2 Diabetes Who Use Daily Insulin and Mealtime Insulin | NCT04848480 | Raffaella Buzzetti | Completed |
| Gliflozin in elderly diabetic patients: A pragmatic intraclass evaluation trial | NCT04796428 | Raffaella Buzzetti | Active |
| Proof of concept study, randomizzato, controllato, aperto e prospettico della durata di un anno per valutare l’efficacia di un trattamento con Saxagliptin / Dapagliflozin + Metformina vs insulina glargine + metformina in soggetti affetti da Diabete Autoimmune dell’Adulto | Raffaella Buzzetti | Active | |
| Sapienza University Mortality and Morbidity Event Rate (SUMMER) study in Diabetes | NCT02311244 | Susanna Morano | Active |
| Confronto di efficacia tra dapagliflozin e trattamenti ipoglicemizzanti non insulinici, diversi dagli inibitori di SGLT2, su endpoints renali nel diabete tipo 2 (DARWIN) | Susanna Morano | Active | |
| A randomized, double blind placebo controlled clinical trial to assess the efficacy and safety of sitagliptin on bone measures in women affected by type 2 diabetes. A gender-oriented approach to address a gender-specific frailty. The SLowDOWN (SitagLiptin in Diabetes for Osteoporosis in WomeN) study DPP4-Inhibitors and bone metabolism in diabetes | Susanna Morano | Active | |
| Aspetti metabolici delle malattie vascolari: rilevanza per lo sviluppo dell’aterosclerosi e identificazione di nuovi target terapeutici e relativi biomarker | Susanna Morano | Active | |
| Nuovi approcci diagnostici e terapeutici per le malattie dismetaboliche (NADITEMM) | Susanna Morano | Active | |
| A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight (REDEFINE 1) | NCT05567796 | Lucio Gnessi | Active |
| Dietary Treatment for Post Bariatric Weight Regain (WRKD) | NCT05896358 | Lucio Gnessi | Active |
| Diet and COVID-19 Vaccination | NCT05163743 | Lucio Gnessi | Recruiting |
| Mechanisms, safety, and efficacy of a very low carbohydrate ketogenic diet for the treatment of non-alcoholic steatohepatitis: a randomized controlled study | Lucio Gnessi | Active | |
| Effetto di una dieta chetogenica sul miglioramento di parametri di Sindrome dell’Ovaio Policistico in donne normopeso e non | Lucio Gnessi | Active |
The Department is also involved in several studies aimed at testing innovative medical devices, which include:
ACS-Orthokine Study on the use of Autologous Conditioned Serum in patients with gonarthrosis resistant to Platelet-Rich Plasma (PRP) treatment;
IStemRewind Study on the use of specific devices for the isolation of stem cells from adipose tissue;
The development of a Smartphone application to support insulin therapy in patients with type 1 diabetes.