Observational Study for the Characterisation of Patients Affected by Any Type of Diabetes and Endocrine Disorders (DiabRegistry)

San Donato Group (GSD)

Status: Not yet enrolling

Conditions: Diabetes; Metabolic Disorders; Arterial Hypertension; Dyslipidemia; Liver Disease (Alcoholic or Not)

Study type: Observational

Funder types: Other

Identifiers

NCT07206875

DiabRegistry

Details and patient eligibility

About

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

Enrollment: 10,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years
• Outpatient Diabetes Unit patient
• Ability to give informed consent

Diagnosis of at least one of the following:

• Metabolic disease, defined as BMI ≥25 Kg/m2
• Type 1 or type 2 diabetes mellitus
• Gestational diabetes
• Monogenic diabetes (MODY)
• Other types of diabetes or dysglycemia
• Dyslipidemia
• Arterial hypertension
• Steatosis liver disease (SLD)

Exclusion criteria

• Age <18 years
• Deny participation at the study
• Recruitment in an interventional protocol
• Patients with missing significant data

Trial design

10,000 participants in 1 patient group

Endocrine-metabolic-disase participants