Observational Study for the Characterisation of Patients Affected by Any Type of Diabetes and Endocrine Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Diabetes, Metabolic Disorders, Arterial Hypertension, Dyslipidemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Retrospective and Prospective Observational Registry for the Characterisation of Patients Affected by Any Type of Diabetes and Endocrine-metabolic Disorders
Overview
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
Primary outcome measures
- GLUCOSE [Time frame: baseline]
- HBA1C [Time frame: baseline]
- Insulin [Time frame: baseline]
- UACR [Time frame: baseline]
- Anthropometric parameters [Time frame: baseline]
- c-pep [Time frame: baseline]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Diabetology Department, San Raffaele Scientific Institute — Milan
Identifiers
NCT: NCT07206875 · DiabRegistry