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

Not yet recruiting

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

• Registration Number: NCT07206875
• Lead Sponsor: IRCCS San Raffaele

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-23
• Status Verified: 2025-10
• Study First Submitted QC: 2025-10-01
• Last Update Submitted: 2025-10-01
• Study First Posted: 2025-10-03
• Last Update Posted: 2025-10-03
• Study Start: 2025-11-01
• Primary Completion: 2026-11
• Study Completion: 2035-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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;

Trial Locations

Locations (1)

Diabetology Department, San Raffaele Scientific Institute; 🇮🇹 Milan, Italy, Italy