Describing the Clinical-laboratory Aspects of Diabetes Through the Creation of a Registry

January 22, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna
        • Contact:
          • Uberto Pagotto, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical-Laboratory Aspects of Diabetes - Family History
Time Frame: through study completion, an average of 26 years

This outcome measure will document and analyze the family history of diabetes in separate assessments:

Diabetes in First-Degree Relatives: Data will be collected on the presence or absence of diabetes in parents, siblings, and offspring. This will be documented as a binary variable (yes/no) for each relative and reported as percentages of participants with affected first-degree relatives.

Diabetes in Extended Family: Information will be collected on the presence of diabetes in second-degree and more distant relatives. This data will be categorized into groups based on the degree of relation and summarized descriptively as percentages of participants with a family history in extended relatives.
through study completion, an average of 26 years
Clinical-Laboratory Aspects of Diabetes - Survival
Time Frame: through study completion, an average of 26 years

This outcome measure will assess patient survival data, including:

Overall Survival (OS): Defined as the time from study enrollment to death from any cause, reported in months.

Life-Threatening Complications: Documented as binary outcomes (yes/no) and categorized by type (e.g., cardiovascular, respiratory).

Each parameter will be recorded and analyzed separately:

Survival status will be evaluated using Kaplan-Meier survival curves and summarized as median survival time with 95% confidence intervals.

Complications will be reported as incidence rates (%) with descriptive statistics.

Clinical and laboratory findings will be analyzed in separate measures to ensure clarity and avoid overlapping Units of Measure.
through study completion, an average of 26 years
Clinical-Laboratory Aspects of Diabetes - Comorbidities
Time Frame: through study completion, an average of 26 years

This outcome measure focuses on the presence of comorbid conditions among participants. The following comorbidities will be assessed:

Hypertension: Documented as a binary variable (present/absent), based on clinical diagnosis and/or medication use.

Cardiovascular Disease: Recorded as a binary variable (present/absent), categorized based on clinical diagnosis (e.g., coronary artery disease, heart failure).

Kidney Disease: Assessed as a binary variable (present/absent), with relevant laboratory test results (e.g., eGFR in mL/min/1.73m²).

Each comorbidity will be analyzed separately, reported as a percentage of participants with the condition, and presented with its respective unit of measurement (e.g., eGFR in mL/min/1.73m² for kidney disease). No aggregation of these conditions will occur within a single measure; each will be reported individually to ensure clarity.
through study completion, an average of 26 years
Psychological Factors in Diabetes Management: Depression, Anxiety, and Quality of Life
Time Frame: through study completion, an average of 26 years

This outcome measure will evaluate psychological factors related to diabetes management and well-being using specific, validated tools.

Each of these psychological aspects will be assessed separately, with their corresponding scales and Units of Measure, to ensure clear reporting and analysis.
through study completion, an average of 26 years
Blood Glucose and HbA1c Levels in Diabetes
Time Frame: through study completion, an average of 26 years

This outcome measure will collect laboratory data on blood glucose and HbA1c levels:

Blood Glucose Levels: Measured in mg/dL, collected as fasting blood glucose or postprandial glucose, reported as means ± standard deviation.

HbA1c: Measured in percentage (%), summarized as mean ± standard deviation. These parameters will be analyzed independently to assess their role in diabetes management and outcomes.
through study completion, an average of 26 years
Aggregated Data on Diabetes Progression and Management
Time Frame: through study completion, an average of 26 years

This outcome measure will aggregate data collected from the diabetes registry, focusing on the following specific parameters:

Diabetes-related Clinical Outcomes: These include metrics such as HbA1c levels (measured in %) and fasting blood glucose (measured in mg/dL), recorded at baseline and during follow-up visits.

Comorbidities: Data on the presence of diabetes-related comorbidities, including hypertension (measured as systolic/diastolic blood pressure in mmHg) and cardiovascular events (binary variable: present/absent).

Medication Use: Types and dosages of diabetes-related medications (e.g., insulin units, oral hypoglycemic agents), reported as frequencies or percentages.

The aggregated data will be used to analyze trends in diabetes progression and management, summarized with descriptive statistics (mean ± standard deviation, percentages). The dataset will also be used for cohort studies to generate new scientific insights or validate existing evidence on diabetes.
through study completion, an average of 26 years
Lipid Profile in Diabetes
Time Frame: through study completion, an average of 26 years

This outcome measure will collect data on the lipid profile in patients with diabetes:

Cholesterol (Total, HDL, LDL): Measured in mg/dL. Triglycerides: Measured in mg/dL. Data will be summarized as means ± standard deviation for each lipid component, with analysis focused on how these markers influence diabetes outcomes.
through study completion, an average of 26 years
Kidney Function Tests in Diabetes
Time Frame: through study completion, an average of 26 years

This outcome measure will collect laboratory data on kidney function in diabetes patients:

Creatinine Levels: Measured in mg/dL. Estimated Glomerular Filtration Rate (eGFR): Calculated based on creatinine levels, age, gender, and race, expressed in mL/min/1.73m².

Urinary Albumin-to-Creatinine Ratio (ACR): Measured in mg/g. These kidney function parameters will be reported independently to assess renal health in diabetes management.
through study completion, an average of 26 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Principal Investigator: Uberto Pagotto, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

December 30, 2050

Study Completion (Estimated)

December 31, 2050

Study Registration Dates

First Submitted

December 3, 2024

First Submitted That Met QC Criteria

January 22, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 22, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REDIA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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