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

NCT06797947 | Not Yet Recruiting

• 1 other identifier: REDIA
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (8)

• Clinical-Laboratory Aspects of Diabetes - Family History

  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

  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

  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

  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

  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

  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

  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

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• \- Patients whose diagnosis of diabetes mellitus is uncertain

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Uberto Pagotto, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Uberto Pagotto, MD

CONTACT

+390512144190; uberto.pagotto@unibo.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 29 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: January 29, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 30, 2050
• Study Completion (Estimated): December 31, 2050
• Last Updated: January 29, 2025

Record last verified: 2024-11

Locations

IT (1)