PrediabetesPHEBiPNCT07653048
Personality Traits and Biochemical Risk Phenotypes
An observational study of Prediabetes and Hyperglycemia, run by Medical Center TOPMED at 1 site in Romania.
Trial summary
This prospective observational study investigates the association between personality traits and routine laboratory abnormalities in adults undergoing routine health assessment. Personality traits are assessed using the Five-Factor Personality Inventory (FFPI), while biochemical data are obtained from routine… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prediabetes, Hyperglycemia, Metabolic Syndrome
- How many people
- 1,000 participants
- Where
- 1 siteRomania
- Study dates
- 1 Oct 2024to 1 Sep 2027
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults undergoing routine health assessment in a clinical setting who complete the Five-Factor Personality Inventory (FFPI) and have routine laboratory data available for evaluation of laboratory health indicators and their association with personality traits.
Who may be able to join
- Adults aged 18 years or older
- Undergoing routine health assessment
- Completion of the Five-Factor Personality Inventory (FFPI)
- Availability of routine laboratory test results
- Provision of written informed consent
Who cannot join
- Age younger than 18 years
- Incomplete FFPI assessment
- Missing or incomplete laboratory data
- Refusal or inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romania1 site, 1 recruiting
- Recruiting
Medical Center TOPMED
Târgu Mureş, Mureș County, 540058
Stefania Diana Nilca, Principal Psychologist, PhD St, 0745404037, diana.nilca@umfst.ro
About this study
Official title: Personality Traits and Biochemical Risk Phenotypes in Adults Undergoing Routine Health Assessment
This prospective observational study investigates the association between personality traits and routine laboratory abnormalities in adults undergoing routine health assessment. Personality traits are assessed using the Five-Factor Personality Inventory (FFPI), while biochemical data are obtained from routine laboratory testing, including markers of glycemic status, liver function, lipid metabolism, renal function, and complete blood count parameters.
The primary objective of the study is to evaluate the association between FFPI personality trait scores and the total number of laboratory abnormalities identified during routine clinical evaluation. Secondary analyses will examine associations between personality traits and glycemic status, fasting plasma glucose concentration, liver function markers, lipid profile parameters, renal function indicators, complete blood count parameters, and the total number of laboratory abnormalities.
The findings may contribute to a better understanding of the relationship between psychological characteristics and biological health indicators and may support the development of more personalized approaches to health promotion, risk assessment, and disease prevention.
Read the detailed description
The study is designed as a prospective observational cohort investigation conducted in adults undergoing routine health assessment. Participants complete the Five-Factor Personality Inventory (FFPI), and clinical and laboratory data are collected as part of routine medical evaluation.
Routine laboratory assessment includes fasting plasma glucose (mg/dL), gamma-glutamyl transferase (GGT, U/L), alanine aminotransferase (ALT, U/L), aspartate aminotransferase (AST, U/L), total cholesterol (mg/dL), serum creatinine (mg/dL), urea (mg/dL), estimated glomerular filtration rate (eGFR, mL/min/1.73 m²), and complete blood count parameters measured according to standard laboratory units. The total number of laboratory abnormalities is defined as the count of laboratory parameters outside their corresponding reference intervals. For the purposes of this study, the total number of laboratory abnormalities serves as an operational indicator of biochemical risk.
The primary objective of the study is to evaluate the association between Five-Factor Personality Inventory (FFPI) personality trait scores and the total number of routine laboratory abnormalities identified during clinical evaluation.
Secondary analyses will examine associations between personality traits and glycemic status, fasting plasma glucose concentration, liver function markers (GGT, ALT, and AST), lipid profile parameters, renal function indicators, and the total number of laboratory abnormalities.
Data are collected prospectively during routine clinical practice. Statistical analyses will evaluate the strength and direction of associations between personality traits and laboratory health indicators while accounting for relevant demographic and clinical variables.
- Conditions
- Prediabetes, Hyperglycemia, Metabolic Syndrome
- Keywords
- Personality Traits, Biomarkers, Prediabetes, Hyperglycemia, Occupational Health, Five-Factor Personality Inventory, Laboratory Abnormalities, Routine Health Assessment
- Medical subject headings
- Prediabetic State, Hyperglycemia, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Routine Health Assessment Cohort | This cohort includes adults undergoing routine health assessment who complete the Five-Factor Personality Inventory (FFPI) and have biochemical laboratory data available from routine clinical evaluation. Collected variables include indicators of glycemic status, liver function, lipid metabolism, renal function, and complete blood count parameters obtained during routine laboratory assessment. Participants undergo routine laboratory assessment, and the total number of laboratory abnormalities is determined based on the count of laboratory parameters outside the corresponding reference intervals. These data are used to evaluate associations between personality traits and biological health indicators. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Laboratory Abnormalities
Total number of routine laboratory parameters outside their corresponding reference intervals, expressed as a count of abnormal laboratory findings. Laboratory parameters include fasting plasma glucose (mg/dL), gamma-glutamyl transferase (GGT, U/L), alanine aminotransferase (ALT, U/L), aspartate aminotransferase (AST, U/L), total cholesterol (mg/dL), serum creatinine (mg/dL), urea (mg/dL), estimated glomerular filtration rate (eGFR, mL/min/1.73 m²), and complete blood count parameters measured according to standard laboratory units.
Measured: At baseline
Secondary outcomes (2)
Five-Factor Personality Inventory (FFPI) Scores
Personality traits assessed using the Five-Factor Personality Inventory (FFPI), including Neuroticism, Extraversion, Agreeableness, Conscientiousness, and Openness dimensions, expressed as standardized questionnaire scores.
Measured: At baseline
Glycemic Status
Classification of participants according to fasting plasma glucose (mg/dL) concentration measured during routine laboratory assessment as:
Normoglycemia (<100 mg/dL) Prediabetes (100-125 mg/dL) Hyperglycemia (≥126 mg/dL or previously diagnosed diabetes mellitus)
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 Oct 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Center TOPMED
- Sponsor type
- University, hospital or other
- Collaborators
- George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
- Responsible party
- Sponsor
- Investigators
- Stefania Diana St Nilca, Principal Psychologist, PhD St, Principal investigator, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Târgu Mureș
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653048
- Sponsor's protocol ID
- PHEBiP-2/2024
- Acronym
- PHEBiP
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Any future data sharing will be considered in accordance with institutional policies, ethical approvals, participant confidentiality requirements, and applicable data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personality Traits and Biochemical Risk Phenotypes in Adults Undergoing Routine Health Assessment
- ClinicalTrials.gov ID
- NCT07653048
- Acronym / sponsor ID
- PHEBiP / PHEBiP-2/2024
- Conditions
- Prediabetes, Hyperglycemia, Metabolic Syndrome
- Keywords
- Personality Traits, Biomarkers, Prediabetes, Hyperglycemia, Occupational Health, Five-Factor Personality Inventory, Laboratory Abnormalities, Routine Health Assessment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Medical Center TOPMEDUniversity, hospital or other
- Collaborators
- George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 17 Jun 2026 (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.
This prospective observational study investigates the association between personality traits and routine laboratory abnormalities in adults undergoing routine health assessment. Personality traits are assessed using the Five-Factor Personality Inventory (FFPI), while biochemical data are obtained from routine laboratory testing, including markers of glycemic status, liver function, lipid metabolism, renal function, and complete blood count parameters.
The primary objective of the study is to evaluate the association between FFPI personality trait scores and the total number of laboratory abnormalities identified during routine clinical evaluation. Secondary analyses will examine associations between personality traits and glycemic status, fasting plasma glucose concentration, liver function markers, lipid profile parameters, renal function indicators, complete blood count parameters, and the total number of laboratory abnormalities.
The findings may contribute to a better understanding of the relationship between psychological characteristics and biological health indicators and may support the development of more personalized approaches to health promotion, risk assessment, and disease prevention.
Detailed description
The study is designed as a prospective observational cohort investigation conducted in adults undergoing routine health assessment. Participants complete the Five-Factor Personality Inventory (FFPI), and clinical and laboratory data are collected as part of routine medical evaluation.
Routine laboratory assessment includes fasting plasma glucose (mg/dL), gamma-glutamyl transferase (GGT, U/L), alanine aminotransferase (ALT, U/L), aspartate aminotransferase (AST, U/L), total cholesterol (mg/dL), serum creatinine (mg/dL), urea (mg/dL), estimated glomerular filtration rate (eGFR, mL/min/1.73 m²), and complete blood count parameters measured according to standard laboratory units. The total number of laboratory abnormalities is defined as the count of laboratory parameters outside their corresponding reference intervals. For the purposes of this study, the total number of laboratory abnormalities serves as an operational indicator of biochemical risk.
The primary objective of the study is to evaluate the association between Five-Factor Personality Inventory (FFPI) personality trait scores and the total number of routine laboratory abnormalities identified during clinical evaluation.
Secondary analyses will examine associations between personality traits and glycemic status, fasting plasma glucose concentration, liver function markers (GGT, ALT, and AST), lipid profile parameters, renal function indicators, and the total number of laboratory abnormalities.
Data are collected prospectively during routine clinical practice. Statistical analyses will evaluate the strength and direction of associations between personality traits and laboratory health indicators while accounting for relevant demographic and clinical variables.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Routine Health Assessment Cohort | – | –This cohort includes adults undergoing routine health assessment who complete the Five-Factor Personality Inventory (FFPI) and have biochemical laboratory data available from routine clinical evaluation. Collected variables include indicators of glycemic status, liver function, lipid metabolism, renal function, and complete blood count parameters obtained during routine laboratory assessment. Participants undergo routine laboratory assessment, and the total number of laboratory abnormalities is determined based on the count of laboratory parameters outside the corresponding reference intervals. These data are used to evaluate associations between personality traits and biological health indicators. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing routine health assessment in a clinical setting who complete the Five-Factor Personality Inventory (FFPI) and have routine laboratory data available for evaluation of laboratory health indicators and their association with personality traits.
Key inclusion criteria (5 listed)
- Adults aged 18 years or older
- Undergoing routine health assessment
- Completion of the Five-Factor Personality Inventory (FFPI)
- Availability of routine laboratory test results
- Provision of written informed consent
Key exclusion criteria (4 listed)
- Age younger than 18 years
- Incomplete FFPI assessment
- Missing or incomplete laboratory data
- Refusal or inability to provide informed consent
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
Number of Laboratory Abnormalities
Time frame: At baseline
Total number of routine laboratory parameters outside their corresponding reference intervals, expressed as a count of abnormal laboratory findings. Laboratory parameters include fasting plasma glucose (mg/dL), gamma-glutamyl transferase (GGT, U/L), alanine aminotransferase (ALT, U/L), aspartate aminotransferase (AST, U/L), total cholesterol (mg/dL), serum creatinine (mg/dL), urea (mg/dL), estimated glomerular filtration rate (eGFR, mL/min/1.73 m²), and complete blood count parameters measured according to standard laboratory units.
2 secondary outcomes
Five-Factor Personality Inventory (FFPI) Scores
Time frame: At baseline
Glycemic Status
Time frame: At baseline
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 17 Jun 2026.
- Individual participant dataSharing planned: Undecided. Any future data sharing will be considered in accordance with institutional policies, ethical approvals, participant confidentiality requirements, and applicable data protection regulations.
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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.
Stefania Diana St Nilca, Principal Psychologist, PhD St principal investigator
George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Târgu Mureș
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 Prediabetes and Hyperglycemia, run by Medical Center TOPMED at 1 site in Romania.
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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 17 Jun 2026. 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 Romania. 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 Stefania Diana St Nilca, Principal Psychologist, PhD St (+40745404037, diana.nilca@umfst.ro), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Laboratory Abnormalities (time frame: At baseline). 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 17 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.