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

Retrospective and Prospective Observational Registry for the Characterisation of Patients Affected by Any Type of Diabetes and Endocrine-metabolic Disorders

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07206875

Acronym

DiabRegistry

Enrollment

10000

Registered

2025-10-03

Start date

2025-11-30

Completion date

2035-11-30

Last updated

2025-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Hypertension, Diabetes, Dyslipidemia, Liver Disease (Alcoholic or Not), Metabolic Disorders

Keywords

diebetes, metabolic disorders, endocrine disorders, observational study

Brief 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, 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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
GLUCOSE	baseline	glucose in milligrams per deciliter;
HBA1C	baseline	glycates hemoglobin in millimoles per mole.
Insulin	baseline	insulin in microunits per milliliter;
UACR	baseline	Urine analysis: albumine in milligrams per liter, creatinine millimoles per liter.
Anthropometric parameters	baseline	BMI: body mass index : weight/height2 = kilogram/cm2
c-pep	baseline	c-peptide in nanograms per milliliter;

Countries

Italy

Contacts

Primary ContactEMANUELA SETOLA, MD, PhD

setola.emanuela@hsr.it+390226432819

Backup ContactAMELIA CARETTO, MD

caretto.amelia@hsr.it+390226436283

Outcome results