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

NCT07206875 | Not Yet Recruiting

• 1 other identifier: DiabRegistry
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

diebetes; metabolic disorders; endocrine disorders; observational study

Outcome Measures

Primary Outcomes (6)

• GLUCOSE

  glucose in milligrams per deciliter;

  baseline

• HBA1C

  glycates hemoglobin in millimoles per mole.

  baseline

• Insulin

  insulin in microunits per milliliter;

  baseline

• UACR

  Urine analysis: albumine in milligrams per liter, creatinine millimoles per liter.

  baseline

• Anthropometric parameters

  BMI: body mass index : weight/height2 = kilogram/cm2

  baseline

• c-pep

  c-peptide in nanograms per milliliter;

  baseline

Study Arms (1)

Endocrine-metabolic-disase participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with diabetes and endocrine-metabolic diseases accessing the care services of the O.U. of Diabetology

You may qualify if:

• 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)

You may not qualify if:

• Age \<18 years
• Deny participation at the study
• Recruitment in an interventional protocol
• Patients with missing significant data

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

Diabetology Department, San Raffaele Scientific Institute

Milan, Italy, 20132, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus; Metabolic Diseases; Hypertension; Dyslipidemias; Liver Diseases; Endocrine System Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Digestive System Diseases

Central Study Contacts

EMANUELA SETOLA, MD, PhD

CONTACT

+390226432819; setola.emanuela@hsr.it

AMELIA CARETTO, MD

CONTACT

+390226436283; caretto.amelia@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MEDICAL DOCTOR

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: October 3, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2035
• Last Updated: October 3, 2025

Record last verified: 2025-10

Locations

IT (1)