Metabolic DiseaseCharmNCT06385431
Obeservational Cohort for Evaluating Future Cardiovascular Disease With High Metabolic Risks
An observational study of Metabolic Disease, run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
Cardiovascular and metabolic diseases refer to a large category of cardiovascular diseases accompanied by a series of metabolic disorders (including dyslipidemia, obesity, abnormal glucose tolerance, diabetes, hypertension, thyroid dysfunction, etc.), which is the primary cause of death and disease burden of Chinese… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disease
- What is being tested?
- observational study
- How many people
- 8,000 participants
- Where
- No sites listed yet
- Study dates
- 28 Apr 2024to 30 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The participants were patients aged 18-70 years with cardiovascular and metabolic disease
Who may be able to join
- 1.18 years old ≤ age ≤70 years old; 2. Have ≥1 cardiovascular and metabolic disease:
- hypertension (systolic blood pressure ≥140mmHg in the resting room and diastolic blood pressure ≥90mmHg in the rest room;Previously diagnosed and taking blood pressure medication);
- Dyslipidemia: [LDL-C≥4.1mmol/L and/or HDL-C<1.0mmol/L and/or TC≥6.2mmol/L and/or TG≥2.3mmol/L];
- fatty liver;
- Obesity (BMI≥28kg/m2 or waist circumference: male ≥90cm, female ≥85cm);
- Abnormal glucose metabolism:
- Impaired fasting blood glucose: fasting blood glucose ≥6.1, <7.0mmol/L, 2h post-glucose load blood glucose<7.8mmol/L And/or impaired glucose tolerance: fasting blood glucose<6.1mmol/L, 2h post-glucose load blood glucose ≥7.8,<11.1mmol/L and/or HbA1c≥5.7, <6.5%; 3. Subjects voluntarily participate in the study
Who cannot join
- Diagnosed type 1 and/or type 2 diabetes;
- Confirmed history of secondary hypertension (renal parenchymatous hypertension, renal artery stenosis, primary aldosteronism, pheochromocytoma, Cushing's syndrome, coarctation of the aorta, obstructive sleep apnea hypopnea syndrome, etc.);
- A history of malignant tumors (other than non-metastatic skin basal cell carcinoma or squamous cell carcinoma or cervical cancer in situ that has been appropriately treated or resected);
- Severe structural heart disease (including valvular heart disease, cardiomyopathy, congenital heart disease);
- Myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack in the last 6 months;
- History of cardiovascular and cerebrovascular surgery/interventional treatment (stent, balloon, thrombectomy, etc.);
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- Pregnant women or those who are breastfeeding;
- Patients with clear immune system abnormalities (systemic lupus erythematosus, etc.);
- Impaired liver and kidney function (ALT, AST more than 3 times the upper limit of normal, eGFR(CKD-EPI)≤60 mL/min/1.73m2);
- Patients who cannot follow through on screening.
Trial locations and contacts
No sites are listed yet.
About this study
Cardiovascular and metabolic diseases refer to a large category of cardiovascular diseases accompanied by a series of metabolic disorders (including dyslipidemia, obesity, abnormal glucose tolerance, diabetes, hypertension, thyroid dysfunction, etc.), which is the primary cause of death and disease burden of Chinese residents.The number of deaths from atherosclerotic cardiovascular disease (ASCVD) in China is about 2.4 million, accounting for 61% of the total cardiovascular deaths, accounting for more than 40% of the all-cause deaths. In Chinese patients with coronary heart disease, 52.9% are complicated with diabetes.Despite the 1.1 million coronary stents implanted in China, there has been no reduction in cardiovascular mortality, which highlights the importance of threshold advancement and the management of metabolic risk factors.
In recent years, the new concept of cardiovascular and metabolic diseases has been actively promoted at home and abroad, and the focus of prevention and treatment strategy of cardiovascular and metabolic diseases has been called for.The project proposed the concept of co-treatment of metabolic diseases based on disorders of blood pressure regulation, disorders of glucose metabolism and disorders of lipid metabolism. Subjects eligible for cardiovascular and metabolic diseases were screened, their past medical records were registered, education and diagnosis and treatment management were conducted.
- Conditions
- Metabolic Disease
- Being tested
- observational study
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyOther
obeservational study with none intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients with cardiovascular and metabolic disease | Not described Receives: Other: observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence rate of cardiovascular and metabolic diseases
Describe the incidence rate of cardiovascular and metabolic diseases(%).
Measured: 2024.04-2026.04
treatment rate of cardiovascular and metabolic diseases
Describe the treatment rate of cardiovascular and metabolic diseases(%)：the number of subjects with treatment/number of all subjects
Measured: 2024.04-2026.04
control rate of cardiovascular and metabolic diseases.
Describe the control rate of cardiovascular and metabolic diseases. (%) number of subjects with effective treatment/ number of subjects with treatment
Measured: 2024.04-2026.04
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start28 Apr 2024 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseaseStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiangqing Kong, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Xiangqing Kong, Phd, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385431
- Sponsor's protocol ID
- Charm
- Acronym
- Charm
- Status last verified
- Apr 2024
- First submitted
- 9 Apr 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obeservational Cohort for Evaluating Future Cardiovascular Disease With High Metabolic Risks
- ClinicalTrials.gov ID
- NCT06385431
- Acronym / sponsor ID
- Charm / Charm
- Conditions
- Metabolic Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 28 Apr 2024 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 26 Apr 2024 (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.
Cardiovascular and metabolic diseases refer to a large category of cardiovascular diseases accompanied by a series of metabolic disorders (including dyslipidemia, obesity, abnormal glucose tolerance, diabetes, hypertension, thyroid dysfunction, etc.), which is the primary cause of death and disease burden of Chinese residents.The number of deaths from atherosclerotic cardiovascular disease (ASCVD) in China is about 2.4 million, accounting for 61% of the total cardiovascular deaths, accounting for more than 40% of the all-cause deaths. In Chinese patients with coronary heart disease, 52.9% are complicated with diabetes.Despite the 1.1 million coronary stents implanted in China, there has been no reduction in cardiovascular mortality, which highlights the importance of threshold advancement and the management of metabolic risk factors.
In recent years, the new concept of cardiovascular and metabolic diseases has been actively promoted at home and abroad, and the focus of prevention and treatment strategy of cardiovascular and metabolic diseases has been called for.The project proposed the concept of co-treatment of metabolic diseases based on disorders of blood pressure regulation, disorders of glucose metabolism and disorders of lipid metabolism. Subjects eligible for cardiovascular and metabolic diseases were screened, their past medical records were registered, education and diagnosis and treatment management were conducted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with cardiovascular and metabolic disease | – | Other: observational study |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The participants were patients aged 18-70 years with cardiovascular and metabolic disease
Key inclusion criteria (7 listed)
- hypertension (systolic blood pressure ≥140mmHg in the resting room and diastolic blood pressure ≥90mmHg in the rest room;Previously diagnosed and taking blood pressure medication);
- Dyslipidemia: [LDL-C≥4.1mmol/L and/or HDL-C<1.0mmol/L and/or TC≥6.2mmol/L and/or TG≥2.3mmol/L];
- fatty liver;
- Obesity (BMI≥28kg/m2 or waist circumference: male ≥90cm, female ≥85cm);
- Abnormal glucose metabolism:
Key exclusion criteria (10 listed)
- Diagnosed type 1 and/or type 2 diabetes;
- Confirmed history of secondary hypertension (renal parenchymatous hypertension, renal artery stenosis, primary aldosteronism, pheochromocytoma, Cushing's syndrome, coarctation of the aorta, obstructive sleep apnea hypopnea syndrome, etc.);
- A history of malignant tumors (other than non-metastatic skin basal cell carcinoma or squamous cell carcinoma or cervical cancer in situ that has been appropriately treated or resected);
- Severe structural heart disease (including valvular heart disease, cardiomyopathy, congenital heart disease);
- Myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack in the last 6 months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational studyobeservational study with none intervention | Other | Patients with cardiovascular and metabolic disease |
Primary outcome
incidence rate of cardiovascular and metabolic diseases
Time frame: 2024.04-2026.04
Describe the incidence rate of cardiovascular and metabolic diseases(%).
treatment rate of cardiovascular and metabolic diseases
Time frame: 2024.04-2026.04
Describe the treatment rate of cardiovascular and metabolic diseases(%)：the number of subjects with treatment/number of all subjects
control rate of cardiovascular and metabolic diseases.
Time frame: 2024.04-2026.04
Describe the control rate of cardiovascular and metabolic diseases. (%) number of subjects with effective treatment/ number of subjects with treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Xiangqing Kong, Phd study director
The First Affiliated Hospital with Nanjing Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Disease, run by The First Affiliated Hospital with Nanjing Medical University.
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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Sun, Phd (13815860536, shunwee@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence rate of cardiovascular and metabolic diseases (time frame: 2024.04-2026.04). The study lists 3 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 26 Apr 2024.