About this trial
The main objective of this retrospective and prospective observational register is to identify anthropometric, clinical, laboratory and/or instrumental markers of disease severity and activity in patients suffering from diabetes, endocrine-metabolic disorders, rare diseases in order to improve their diagnosis, monitoring and treatment processes. The Registry is monocentric, observational prospective and retrospective. No additional procedures to those of normal clinical practice are planned, and neither diagnostic approaches nor experimental drugs/prescriptions will be applied. The data under study (demographic, anthropometric, clinical and care characteristics) will be collected as part of outpatient visits of the Diabetes Outpatient Clinic or admission to Diabetes Day Hospital.
In case of outpatients, the observation will start at the diagnosis or during the first outpatient visit and will end with the last outpatient visit performed within the total time foreseen for the duration of the study.
The study will start once the regulatory authorizations are completed, and is expected to last at least 10 years with the possibility of extension
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Outpatient Diabetes Unit patient
Ability to give informed consent
Metabolic disease, defined as BMI ≥25 Kg/m2
Disqualifiers
Age <18 years
Deny participation at the study
Recruitment in an interventional protocol
Patients with missing significant data
Trial population
Patients with diabetes and endocrine-metabolic diseases accessing the care services of the O.U. of Diabetology
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
GLUCOSE
glucose in milligrams per deciliter;
HBA1C
glycates hemoglobin in millimoles per mole.
Insulin
insulin in microunits per milliliter;
UACR
Urine analysis: albumine in milligrams per liter, creatinine millimoles per liter.
Sponsors and contacts
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