Frailty Clinical Trial
— PROMETEOOfficial title:
PRecisiOn MEdicine to Target Frailty of Endocrine-metabolic Origin
NCT number | NCT04856683 |
Other study ID # | PROMETEO |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 10, 2020 |
Est. completion date | August 9, 2024 |
This is a multicenter, observational, retrospective and prospective study for the evaluation of precision medicine to target frailty of endocrine-metabolic origin, with a genetic study.
Status | Recruiting |
Enrollment | 1100 |
Est. completion date | August 9, 2024 |
Est. primary completion date | August 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - presence of endocrine and metabolic diseases (hypothalamic-pituitary-gonadal and adrenal diseases, type 2 diabetes mellitus, and bone diseases); - signed informed consent to participate in the study. |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliero-Universitaria Careggi | Florence | |
Italy | Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milan | |
Italy | Azienda Ospedaliero-Universitaria Policlinico Umberto I | Rome | |
Italy | Ospedale San Giovanni Calibita-Fatebenefratelli Fondazione Fatebenefratelli per la Ricerca e la Formazione Sanitaria e Sociale | Rome | |
Italy | Azienda Ospedaliero-Universitaria Senese | Siena |
Lead Sponsor | Collaborator |
---|---|
University of Roma La Sapienza |
Italy,
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* Note: There are 55 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite Clinical Score | To derive a Composite Clinical Score able to identify endocrine fragile patients (occurrence of at least one of the following events: falls, disability, hospitalization, and mortality within the previous 18-months). | Baseline | |
Primary | Prediction of frailty | Validation of Composite Clinical Score to predict frailty occurrence | Baseline | |
Secondary | Peripheral blood mononuclear cell subpopulations | Number of cells (number per mm3) of peripheral blood mononuclear cell subpopulations | Baseline | |
Secondary | Molecular profiling | Circulating miRNA in blood samples from patients with adrenal and gonadal diseases | Baseline | |
Secondary | Steroid profiling | Steroid metabolites assessed by liquid chromatography-mass spectrometry (LC-MS/MS) | Baseline | |
Secondary | Measure of vascular flows though contrast enhanced ultrasound in endocrine glands | Coupling vascular glandular inflow with hormonal outflow | Baseline | |
Secondary | Measure of liver vascular inflow through 4 dimensional (4D)-flow MRI | Coupling liver vascular inflow with liver glucocorticoid metabolism | Baseline | |
Secondary | Serotonin Transporter 5-HTTLPR polymorphism | To study the effects of Serotonin Transporter 5-HTTLPR polymorphism on gastrointestinal intolerance to metformin in a population of T2D subjects and its relationship with glycometabolic control | Baseline | |
Secondary | Circulating microRNAs | To evaluate circulating microRNAs in blood samples from patients with T2D before and after GLP1-receptor agonist or DPP4 inhibitors therapy, in order to identify markers predicting treatment response, therapeutic efficacy and side effects | Baseline and post 6 months | |
Secondary | Gene polymorphisms | To evaluate gene polymorphisms in blood samples from patients with T2D before and after GLP1-RA or DPP4 inhibitors therapy, in order to identify markers predicting treatment response, therapeutic efficacy and side effects | Baseline and post 6 months | |
Secondary | Cardio-metabolic stratification risk | To elaborate a risk stratification approach for cardiovascular, metabolic and cerebrovascular outcomes in pituitary patients aimed to personalize treatment and follow-up in pituitary diseases. | Baseline | |
Secondary | Psychological function | Psychological function assessed by QoL questionnaire in pituitary diseases | Baseline | |
Secondary | Osteoporosis stratification risk | Gene analysis to elaborate a risk screening panel for osteoporosis | Baseline | |
Secondary | Epigenetic biomarkers | To individuate possible serum epigenetic biomarkers of osteoporosis status and fragility fractures risk | Baseline | |
Secondary | Multiple endocrine and metabolic comorbidities | To identify patients with multiple endocrine and metabolic comorbidities and assess the incidence of major clinical events using regional registries | Baseline | |
Secondary | Inappropriate therapeutic regimen | To individuate inappropriate therapeutic regimen (drug prescriptions or suboptimal adherence) in patients with multiple endocrine and metabolic comorbidities | Baseline |
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