- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07595094
Phenotypic Age Acceleration (PhenoAgeAccel) for Joint Prediction of Disease Risk, Mortality Risk, Life Expectancy, and Disease-Free Healthspan in Major Chronic Diseases
The goal of this observational study is to learn about the ability of Phenotypic Age Acceleration (PhenoAgeAccel) to predict four key health outcomes in Chinese people with or at risk of major chronic diseases: the risk of developing new chronic diseases, the risk of dying, life expectancy, and disease-free healthspan.
The main questions this study aims to answer are:
- Does higher PhenoAgeAccel increase the risk of developing major chronic diseases (including diabetes, dementia, cancer, and chronic respiratory diseases) in Chinese adults?
- Does higher PhenoAgeAccel increase the risk of death from all causes in Chinese adults?
- How do life expectancy and disease-free healthspan differ between people with high versus low PhenoAgeAccel?
Who can take part in this study? Adults aged 35 or above years old who receive routine care at participating hospitals in China, have complete routine blood test data available, and have provided consent to use their health information for research purposes.
What will participants go through? Participants will receive their usual medical care as they normally would. No new treatments, tests, or procedures will be performed specifically for this study. We will collect data from their medical records, including blood test results used to calculate PhenoAgeAccel, diagnoses of new diseases, and dates of death.
What are the potential benefits? Participants will not receive direct personal benefits from taking part in this study. However, the information learned may help us better understand biological aging and improve future risk assessment and health management for people with chronic diseases.
Is this study safe? Yes. This is an observational study that does not involve any new drugs, devices, or invasive procedures. All data used in the study will be de-identified and kept strictly confidential to protect participants' privacy.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Xi-jian Dai, Doctor
- Phone Number: 13755756959
- Email: daixjdoctor@126.com
Study Locations
-
-
Jiangxi
-
Nanchang, Jiangxi, China, 330006
- Recruiting
- Second Affiliated Hospital of Nanchang University
-
Contact:
- Xi-Jian Dai Xi-Jian Dai, MD
- Phone Number: +86-137-5575-6959
- Email: daixjdoctor@126.com
-
Contact:
- Email: daixjdoctor@126.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults aged 35-73 years old. Complete routine blood test data available at baseline to calculate Phenotypic -Age (including albumin, alkaline phosphatase, creatinine, glucose, C-reactive protein, lymphocyte percentage, mean corpuscular volume, red cell distribution width, and white blood cell count).
Complete demographic and clinical data (e.g., sex, BMI, comorbidities) available at baseline.
- Consent to use routine medical data for research follow-up analysis.
Exclusion Criteria:
- Presence of end-stage diseases (e.g., end-stage liver/renal failure) other than the major chronic diseases of interest at baseline.
- Key baseline data missing, making Phenotypic Age calculation impossible. Incomplete follow-up information or inability to confirm outcomes (e.g., death, disease onset) via database linkage.
- Refusal to participate in the study or withdrawal of informed consent.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Non-accelerated PhenoAge Group
Participants with normal biological aging, defined as Phenotypic Age Acceleration ≤ 0. No study-specific intervention is administered; all participants receive routine clinical care as usual.
|
This is an observational study with no study-specific intervention.
All participants receive their routine standard medical care as usual.
No new drugs, devices, procedures, or behavioral modifications are assigned as part of this research.
|
|
Mildly Accelerated PhenoAge Group
Participants with mild biological aging acceleration, defined as 0 < Phenotypic Age Acceleration < median.
No study-specific intervention is administered; all participants receive routine clinical care as usual.
|
This is an observational study with no study-specific intervention.
All participants receive their routine standard medical care as usual.
No new drugs, devices, procedures, or behavioral modifications are assigned as part of this research.
|
|
Severely Accelerated PhenoAge Group
Participants with severe biological aging acceleration, defined as Phenotypic Age Acceleration ≥ median.
No study-specific intervention is administered; all participants receive routine clinical care as usual.
|
This is an observational study with no study-specific intervention.
All participants receive their routine standard medical care as usual.
No new drugs, devices, procedures, or behavioral modifications are assigned as part of this research.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Major Chronic Diseases
Time Frame: Baseline through study completion, average 10 years
|
Composite incidence of new-onset major chronic diseases, including type 2 diabetes, dementia, cancer, and chronic respiratory diseases, defined by ICD-10 codes from electronic medical records.
|
Baseline through study completion, average 10 years
|
|
All-Cause Mortality
Time Frame: Baseline through study completion, average 10 years
|
All-cause mortality, defined as death from any cause, identified through linkage with death registration databases.
|
Baseline through study completion, average 10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Life Expectancy
Time Frame: Baseline through study completion, average 10 years
|
Estimated remaining life expectancy stratified by biological aging status (PhenoAgeAccel) using parametric survival models.
|
Baseline through study completion, average 10 years
|
|
Disease-Free Healthspan
Time Frame: Baseline through study completion, average 10 years
|
Estimated years of life free from major chronic diseases, calculated as the difference between life expectancy and time spent with chronic diseases
|
Baseline through study completion, average 10 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIT-O-2024-136
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Phenotypic Age Acceleration
-
Société des Produits Nestlé (SPN)Completed
-
Bright Dairy & Food Co., LtdCompleted
-
Sana'a UniversityNot yet recruitingAcceleration of Tooth Movement
-
Kufa UniversityCompletedPhotobiomodulation Therapy | Orthodontic Treatment AccelerationIraq
-
Ethiopian Public Health InstituteWageningen University; Micronutrient InitiativeCompletedGrowth Acceleration | Infant MorbidityEthiopia
-
University of California, DavisCompletedGrowth Acceleration | Growth RetardationUnited States
-
Beni-Suef UniversityRecruitingAcceleration of Tooth MovementEgypt
-
Cairo UniversityRecruitingOrthodontics | Platelet-Rich Fibrin | AccelerationEgypt
-
Jordan University of Science and TechnologyCompletedPiezocision | Acceleration of Tooth Movement
-
Ege UniversityBuca Women Birth and Child Diseases HospitalCompletedGrowth Acceleration | Development, Infant | Breastfeeding, Exclusive | AttachmentTurkey
Clinical Trials on No Intervention (Observational Study)
-
Drexel UniversityCompletedOsteoporosisUnited States
-
The Aurum Institute NPCKarolinska Institutet; Ludwig-Maximilians - University of Munich; University... and other collaboratorsUnknownRespiratory Tract Infections | Tuberculosis, PulmonaryMozambique, South Africa, Tanzania, Gambia
-
Hospital Universitario La Paz3MVX CCB and Agaplesion Markus Krankenhaus, Frankfurt a.M., Germany.; Department...RecruitingEmbolism | Atrial Fibrillation | Arrhythmia | Stroke, Acute | Stroke Sequelae | AblationSpain
-
University Hospital, Basel, SwitzerlandCompletedPostoperative Complications | Intraoperative Complications | Patient Safety | Risk ManagementNew Zealand, Switzerland, United States, Netherlands, Spain, Austria, Turkey, United Kingdom, Australia, Greece, Ireland, Italy
-
Hôpital Necker-Enfants MaladesUnknown
-
University Health Network, TorontoNot yet recruitingCardiac Surgery Requiring Cardiopulmonary Bypass
-
Gulbenkian Institute for Molecular MedicineCUF Tejo Hospital; Hospital CUF Descobertas, Lisbon, Portugal; Hospital da Luz...RecruitingMicrobiome | Colorectal Cancer Screening | Colorectal Cancer (CRC)Portugal
-
The First Affiliated Hospital of Xinxiang Medical...Anyang Cancer Hospital; Xinxiang Central Hospital of Henan province; Inner Huang... and other collaboratorsNot yet recruiting
-
Liverpool School of Tropical MedicineLondon School of Hygiene and Tropical Medicine; Wellcome Trust; University of... and other collaboratorsRecruitingKidney Diseases | Chronic Kidney Diseases | Non-communicable Disease | Non-Communicable Chronic DiseasesMalawi
-
Nanfang Hospital of Southern Medical UniversityThe First Affiliated Hospital of Anhui Medical University; Xiangya Hospital... and other collaboratorsRecruiting