Clinical trial NCT06797947: Describing the Clinical-laboratory Aspects of Diabetes Through the Creation of a Registry
Official title: Describing the Clinical-laboratory Aspects of Diabetes by Creating a Registry in Which to Census All Newly Diagnosed or Already Diagnosed Cases After 1/1/2000 at the Endocrinology and Diabetes Prevention and Treatment Unit
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabetes
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participation in the study will be offered consecutively to each patient with newly diagnosed diabetes mellitus evaluated at theU.O. of Endocrinology and Diabetes Prevention and Care.

Brief summary: The main objective of the study is to describe the clinical-laboratory aspects of diabetes by creating a registry in which to census all newly diagnosed or already diagnosed cases after 1/1/2000 at the O.U. of Endocrinology and Diabetes Prevention and Care.

Detailed description: The main objective of the study is to describe the clinical-laboratory aspects of diabetes by creating a registry in which to census all newly diagnosed or already diagnosed cases after 1/1/2000 at the O.U. of Endocrinology and Diabetes Prevention and Care.

The clinical-laboratory aspects covered by this study also include family history, survival, comorbidities, psychological aspects, and in any case all those data that add relevant scientific information. This registry may be used to review the OU's case history and to confirm or obtain new scientific evidence on diabetes through cohort studies conducted using the data that will be recorded.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Newly or previously diagnosed patients with diabetes mellitus at any stage of disease
* Obtaining informed consent

Exclusion Criteria:

- Patients whose diagnosis of diabetes mellitus is uncertain

Primary outcomes:
measure: Clinical-Laboratory Aspects of Diabetes - Family History
timeFrame: through study completion, an average of 26 years
measure: Clinical-Laboratory Aspects of Diabetes - Survival
timeFrame: through study completion, an average of 26 years
measure: Clinical-Laboratory Aspects of Diabetes - Comorbidities
timeFrame: through study completion, an average of 26 years
measure: Psychological Factors in Diabetes Management: Depression, Anxiety, and Quality of Life
timeFrame: through study completion, an average of 26 years
measure: Blood Glucose and HbA1c Levels in Diabetes
timeFrame: through study completion, an average of 26 years
measure: Aggregated Data on Diabetes Progression and Management
timeFrame: through study completion, an average of 26 years
measure: Lipid Profile in Diabetes
timeFrame: through study completion, an average of 26 years
measure: Kidney Function Tests in Diabetes
timeFrame: through study completion, an average of 26 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Uberto Pagotto, MD
role: PRINCIPAL_INVESTIGATOR
References: