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NCT Number: NCT07206875

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

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Key information

Conditions

Diabetes Arterial Hypertension Cardiovascular Diseases Diabetes Mellitus Digestive System Diseases Dyslipidemia Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hypertension Lipid Metabolism Disorders Liver Disease (Alcoholic or Not) Liver Diseases Metabolic Diseases Metabolic Disorders Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Diabetology Department, San Raffaele Scientific Institute

Milan, Italy, 20132

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. GLUCOSE

    Time frame: baseline

    glucose in milligrams per deciliter;

  2. HBA1C

    Time frame: baseline

    glycates hemoglobin in millimoles per mole.

  3. Insulin

    Time frame: baseline

    insulin in microunits per milliliter;

  4. UACR

    Time frame: baseline

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

  5. Anthropometric parameters

    Time frame: baseline

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

  6. c-pep

    Time frame: baseline

    c-peptide in nanograms per milliliter;

Study contacts

Contact information is provided by the study sponsor or research team.

AMELIA CARETTO, MD

CONTACT

[email protected]

+390226436283

EMANUELA SETOLA, MD, PhD

CONTACT

[email protected]

+390226432819

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

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

Acronym: DiabRegistry

Important dates

Study start
2025
Primary completion
2026
Study completion
2035
First posted
Oct 3, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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