Observational registry of patients with diabetes and hormone or metabolic disorders
Records clinical data from patients with diabetes and metabolic or hormone disorders over time.
Key facts
- Who runs it
- IRCCS San Raffaele
- Where
- Milan, ItalySee the site
- Trial code
- Registry title
- Observational Study for the Characterisation of Patients Affected by Any Type of Diabetes and Endocrine Disorders
- Status
- Recruiting
- People taking part
- 10,000 people, planned
- Started
- 3 Nov 2025
- Expected to end
- Nov 2035
- Type of study
- Observational
- Record updated
- 3 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who attend a diabetes outpatient clinic and have diabetes or a related metabolic problem, such as high blood pressure, high blood fats or fatty liver.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- At least one of these: BMI 25 Kg/m2 or higher, type 1 or type 2 diabetes, gestational diabetes, monogenic diabetes (MODY), other types of diabetes or dysglycemia, dyslipidemia, arterial hypertension, or steatosis liver disease (SLD).
Main reasons for not taking part
- Under 18 years old
- Refuses to take part in the study
- Already in an interventional protocol
- Missing significant data
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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)
Who cannot take part
- Age <18 years
- Deny participation at the study
- Recruitment in an interventional protocol
- Patients with missing significant data
Where in Italy
- Diabetology Department, San Raffaele Scientific InstituteMilan, ItalyContact: EMANUELA SETOLA, MD, PhDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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
The group in the trial
- Endocrine-metabolic-disase participants
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Retrospective and Prospective Observational Registry for the Characterisation of Patients Affected by Any Type of Diabetes and Endocrine-metabolic Disorders
- Plain-language title
- Observational registry of patients with diabetes and hormone or metabolic disordersGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 3 November 2026