DiabetesNCT06797947
Describing the Clinical-laboratory Aspects of Diabetes Through the Creation of a Registry
An observational study of Diabetes, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- How many people
- 10,000 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2025to 31 Dec 2050
- How long will I take part?
- 29 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age >18 years
- Newly or previously diagnosed patients with diabetes mellitus at any stage of disease
- Obtaining informed consent
Who cannot join
- Patients whose diagnosis of diabetes mellitus is uncertain
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Uberto Pagotto, MD, +390512144190, uberto.pagotto@unibo.it
Uberto Pagotto, MD
About this study
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
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.
Read the 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.
- Conditions
- Diabetes
- Medical subject headings
- Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 26 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study startJan 2025 (estimated)
- Primary completion30 Dec 2050 (estimated)
- Study completion31 Dec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 29 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Uberto Pagotto, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797947
- Sponsor's protocol ID
- REDIA
- Status last verified
- Nov 2024
- First submitted
- 3 Dec 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06797947
- Acronym / sponsor ID
- REDIA
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- 30 Dec 2050 (estimated)
- Study completion
- 31 Dec 2050 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 29 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age >18 years
- Newly or previously diagnosed patients with diabetes mellitus at any stage of disease
- Obtaining informed consent
Key exclusion criteria (1 listed)
- Patients whose diagnosis of diabetes mellitus is uncertain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Uberto Pagotto, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Uberto Pagotto, MD (+390512144190, uberto.pagotto@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical-Laboratory Aspects of Diabetes - Family History (time frame: through study completion, an average of 26 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.