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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS San Raffaele

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Outpatient Diabetes Unit patient

Ability to give informed consent

Metabolic disease, defined as BMI ≥25 Kg/m2

Disqualifiers

Age <18 years

Deny participation at the study

Recruitment in an interventional protocol

Patients with missing significant data

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

10,000 Participants
are grouped into 1 trial group
Group A: Endocrine-metabolic-disase participants

Trial outcomes

Primary outcomes

1

GLUCOSE

glucose in milligrams per deciliter;

Time frame
baseline
2

HBA1C

glycates hemoglobin in millimoles per mole.

Time frame
baseline
3

Insulin

insulin in microunits per milliliter;

Time frame
baseline
4

UACR

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

Time frame
baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: