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

Condition(s) studied

Study 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

Eligibility

Primary outcome measure(s)

• 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 sites (1)

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