DiabetesDiabRegistryNCT07206875
Observational Study for the Characterisation of Patients Affected by Any Type of Diabetes and Endocrine Disorders
An observational study of Diabetes and Metabolic Disorders, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Metabolic Disorders, Arterial Hypertension
- How many people
- 10,000 participants
- Where
- 1 siteItaly
- Study dates
- 3 Nov 2025to Nov 2035
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diabetes and endocrine-metabolic diseases accessing the care services of the O.U. of Diabetology
Who may be able to join
- 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
Show all 12Show fewer
- Gestational diabetes
- Monogenic diabetes (MODY)
- Other types of diabetes or dysglycemia
- Dyslipidemia
- Arterial hypertension
- Steatosis liver disease (SLD)
Who cannot join
- Age <18 years
- Deny participation at the study
- Recruitment in an interventional protocol
- Patients with missing significant data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Diabetology Department, San Raffaele Scientific Institute
Milan, Italy, 20132
About this study
Official title: Retrospective and Prospective Observational Registry for the Characterisation of Patients Affected by Any Type of Diabetes and Endocrine-metabolic Disorders
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
- Conditions
- Diabetes, Metabolic Disorders, Arterial Hypertension, Dyslipidemia, Liver Disease (Alcoholic or Not)
- Keywords
- diebetes, metabolic disorders, endocrine disorders, observational study
- Medical subject headings
- Diabetes Mellitus, Metabolic Diseases, Hypertension, Dyslipidemias, Liver Diseases, Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Endocrine-metabolic-disase participants | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
GLUCOSE
glucose in milligrams per deciliter;
Measured: baseline
HBA1C
glycates hemoglobin in millimoles per mole.
Measured: baseline
Insulin
insulin in microunits per milliliter;
Measured: baseline
UACR
Urine analysis: albumine in milligrams per liter, creatinine millimoles per liter.
Measured: baseline
Anthropometric parameters
BMI: body mass index : weight/height2 = kilogram/cm2
Measured: baseline
c-pep
c-peptide in nanograms per milliliter;
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start3 Nov 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EMANUELA SETOLA, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206875
- Sponsor's protocol ID
- DiabRegistry
- Acronym
- DiabRegistry
- Status last verified
- Oct 2026
- First submitted
- 23 Jul 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective and Prospective Observational Registry for the Characterisation of Patients Affected by Any Type of Diabetes and Endocrine-metabolic Disorders
- ClinicalTrials.gov ID
- NCT07206875
- Acronym / sponsor ID
- DiabRegistry / DiabRegistry
- Conditions
- Diabetes, Metabolic Disorders, Arterial Hypertension, Dyslipidemia, Liver Disease (Alcoholic or Not)
- Keywords
- diebetes, metabolic disorders, endocrine disorders, observational study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2035 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endocrine-metabolic-disase participants | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diabetes and endocrine-metabolic diseases accessing the care services of the O.U. of Diabetology
Key inclusion criteria (12 listed)
- Age ≥18 years
- Outpatient Diabetes Unit patient
- Ability to give informed consent
- Metabolic disease, defined as BMI ≥25 Kg/m2
- Type 1 or type 2 diabetes mellitus
Key exclusion criteria (4 listed)
- Age <18 years
- Deny participation at the study
- Recruitment in an interventional protocol
- Patients with missing significant data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
GLUCOSE
Time frame: baseline
glucose in milligrams per deciliter;
HBA1C
Time frame: baseline
glycates hemoglobin in millimoles per mole.
Insulin
Time frame: baseline
insulin in microunits per milliliter;
UACR
Time frame: baseline
Urine analysis: albumine in milligrams per liter, creatinine millimoles per liter.
Anthropometric parameters
Time frame: baseline
BMI: body mass index : weight/height2 = kilogram/cm2
c-pep
Time frame: baseline
c-peptide in nanograms per milliliter;
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Metabolic Disorders, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact EMANUELA SETOLA, MD, PhD (+390226432819, setola.emanuela@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GLUCOSE (time frame: baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026; AzTrials last refreshed its copy on 6 Nov 2026.