ObesityNCT05156580
Tongzhou Cohort Study
An observational study of Obesity and Hypertension, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
Long-term Impact of Overweight/Obesity and Hypertension on Cardiovascular Risk in Middle-aged and Elderly Adults Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Hypertension
- How many people
- 31,080 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2016to 1 Sep 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults undergoing routine physical examinations at community health service centers in Tongzhou, China.
Who may be able to join
- Ages of ≥ 45 years
- Participants from routine health examinations at Tongzhou Community Health Service Center
- Availability for follow-up until 2026
- No major barriers to provide written consent
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
About this study
Official title: Long-term Impact of Overweight/Obesity and Hypertension on Cardiovascular Risk in Middle-aged and Elderly Adults: A Cohort Study
Long-term Impact of Overweight/Obesity and Hypertension on Cardiovascular Risk in Middle-aged and Elderly Adults
Read the detailed description
Overweight and obesity are major risk factors associated with the development of hypertension, poor blood pressure control, and adverse cardiovascular outcomes. However, evidence regarding the long-term impact of overweight/obesity and hypertension on cardiovascular risk in middle-aged and elderly populations remains limited. Therefore, the present study aims to evaluate the long-term effects of overweight/obesity and hypertension on cardiovascular risk in middle-aged and elderly adults.Additionally, a subgroup analysis will be conducted in participants with sarcopenia to assess the influence of blood pressure on prognosis, exploring potential interactions between muscle loss, hypertension, and cardiovascular outcomes.
- Conditions
- Obesity, Hypertension
- Being tested
- No intervention
- Keywords
- Obesity, Hypertension, Cardiovascular risk
- Medical subject headings
- Obesity, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observational study without any intervention
| Study group | Role | What they receive |
|---|---|---|
| Obese hypertensive group | Patients who were diagnosed with obesity (body mass index (BMI)≥28kg/m2) and hypertension (systolic blood pressure (SBP)/diastolic blood pressure (DBP) ≥ 140/90 mmHg). Receives: Other: No intervention | |
| Overweight hypertensive group | Overweight patients (24 kg/m2≤BMI≤28 kg/m2) diagnosed with hypertension (SBP/DBP≥140/90 mmHg). Receives: Other: No intervention | |
| Lean hypertensive group | Lean patients (BMI ≤ 24 kg/m2) diagnosed with hypertension (SBP/DBP ≥ 140/90 mmHg). Receives: Other: No intervention | |
| Lean normotensive | Lean patients (BMI ≤ 24 kg/m2) diagnosed with normotensive (SBP/DBP < 140/90 mmHg). Receives: Other: No intervention | |
| Overweight normotensive | Overweight patients (24 kg/m2≤BMI≤28 kg/m2) diagnosed with normotensive (SBP/DBP<140/90 mmHg) Receives: Other: No intervention | |
| Obese normotensive | Patients who were diagnosed with obesity (BMI≥28kg/m2) and normotensive (SBP/DBP<140/90 mmHg). Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with major adverse cardiovascular events (MACEs)
Percentage of participants with major adverse cardiovascular events (MACEs), including all-cause death, nonfatal myocardial infarction (MI), nonfatal stroke and coronary revascularization.
Measured: 2021-2026
Secondary outcomes (9)
Percentage of participants with all-cause death
Percentage of participants with cardiovascular, non-cardiovascular and undetermined death.
Measured: 2021-2026
Percentage of participants with MI
Percentage of participants with fatal and nonfatal MI.
Measured: 2021-2026
Percentage of participants with stroke
Percentage of participants with fatal and nonfatal stroke.
Measured: 2021-2026
Percentage of participants undergoing coronary revascularization
Percentage of participants undergoing ischemia- and non-ischemia-driven coronary revascularization.
Measured: 2021-2026
Change in BP control rate
Change in BP control rate (office BP: SBP < 140 mmHg and DBP < 90 mmHg) from baseline to follow-up.
Measured: 2021-2026
Change in SBP
Change in SBP from baseline to follow-up.
Measured: 2021-2026
Change in estimated glomerular filtration rate (eGFR)
Change in estimated glomerular filtration rate (eGFR) in ml/min/1.73m2 from baseline to follow-up.
Measured: 2021-2026
Change in low-density lipoprotein-cholesterol (LDL-c)
Change in low-density lipoprotein-cholesterol (LDL-c) in mmol/L from baseline to follow-up.
Measured: 2021-2026
Percentage of participants with Metabolic dysfunction-associated steatotic liver disease (MASLD)
Percentage of participants with Metabolic dysfunction-associated steatotic liver disease.
Measured: 2021-2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start1 Jul 2016
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Other
- Enrolment
- 31,080 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tongzhou Yongshun Community Health Service, Beijing Tongzhou Lucheng Community Health Service, Beijing Tongzhou Xuxinzhuang Community Health Service
- Responsible party
- Sponsor
- Investigators
- Rongchong Huang, M.D., Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156580
- Sponsor's protocol ID
- 2021-P2-163-01
- Status last verified
- Aug 2024
- First submitted
- 24 Nov 2021
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang G, Zhao Y, Li Z, Li D, Zhao F, Hao J, Yang C, Song J, Gu X, Huang R. Association between novel inflammatory markers and non-alcoholic fatty liver disease: a cross-sectional study. Eur J Gastroenterol Hepatol. 2024 Feb 1;36(2):203-209. doi: 10.1097/MEG.0000000000002686. Epub 2023 Dec 1.
PubMed 38047735
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Impact of Overweight/Obesity and Hypertension on Cardiovascular Risk in Middle-aged and Elderly Adults: A Cohort Study
- ClinicalTrials.gov ID
- NCT05156580
- Acronym / sponsor ID
- 2021-P2-163-01
- Conditions
- Obesity, Hypertension
- Keywords
- Obesity, Hypertension, Cardiovascular risk
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 31,080 participants (actual)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Collaborators
- Beijing Tongzhou Yongshun Community Health Service, Beijing Tongzhou Lucheng Community Health Service, Beijing Tongzhou Xuxinzhuang Community Health Service
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 14 Dec 2021 (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.
Long-term Impact of Overweight/Obesity and Hypertension on Cardiovascular Risk in Middle-aged and Elderly Adults
Detailed description
Overweight and obesity are major risk factors associated with the development of hypertension, poor blood pressure control, and adverse cardiovascular outcomes. However, evidence regarding the long-term impact of overweight/obesity and hypertension on cardiovascular risk in middle-aged and elderly populations remains limited. Therefore, the present study aims to evaluate the long-term effects of overweight/obesity and hypertension on cardiovascular risk in middle-aged and elderly adults.Additionally, a subgroup analysis will be conducted in participants with sarcopenia to assess the influence of blood pressure on prognosis, exploring potential interactions between muscle loss, hypertension, and cardiovascular outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Obese hypertensive group | – | Other: No interventionPatients who were diagnosed with obesity (body mass index (BMI)≥28kg/m2) and hypertension (systolic blood pressure (SBP)/diastolic blood pressure (DBP) ≥ 140/90 mmHg). |
| Overweight hypertensive group | – | Other: No interventionOverweight patients (24 kg/m2≤BMI≤28 kg/m2) diagnosed with hypertension (SBP/DBP≥140/90 mmHg). |
| Lean hypertensive group | – | Other: No interventionLean patients (BMI ≤ 24 kg/m2) diagnosed with hypertension (SBP/DBP ≥ 140/90 mmHg). |
| Lean normotensive | – | Other: No interventionLean patients (BMI ≤ 24 kg/m2) diagnosed with normotensive (SBP/DBP < 140/90 mmHg). |
| Overweight normotensive | – | Other: No interventionOverweight patients (24 kg/m2≤BMI≤28 kg/m2) diagnosed with normotensive (SBP/DBP<140/90 mmHg) |
| Obese normotensive | – | Other: No interventionPatients who were diagnosed with obesity (BMI≥28kg/m2) and normotensive (SBP/DBP<140/90 mmHg). |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing routine physical examinations at community health service centers in Tongzhou, China.
Key inclusion criteria (4 listed)
- Ages of ≥ 45 years
- Participants from routine health examinations at Tongzhou Community Health Service Center
- Availability for follow-up until 2026
- No major barriers to provide written consent
Key exclusion criteria (1 listed)
- NA
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 |
|---|---|---|
| No interventionThis is an observational study without any intervention | Other | Lean hypertensive group, Lean normotensive, Obese hypertensive group, Obese normotensive, Overweight hypertensive group, Overweight normotensive |
Primary outcome
Percentage of participants with major adverse cardiovascular events (MACEs)
Time frame: 2021-2026
Percentage of participants with major adverse cardiovascular events (MACEs), including all-cause death, nonfatal myocardial infarction (MI), nonfatal stroke and coronary revascularization.
9 secondary outcomes
Percentage of participants with all-cause death
Time frame: 2021-2026
Percentage of participants with MI
Time frame: 2021-2026
Percentage of participants with stroke
Time frame: 2021-2026
Percentage of participants undergoing coronary revascularization
Time frame: 2021-2026
Change in BP control rate
Time frame: 2021-2026
Change in SBP
Time frame: 2021-2026
Change in estimated glomerular filtration rate (eGFR)
Time frame: 2021-2026
Change in low-density lipoprotein-cholesterol (LDL-c)
Time frame: 2021-2026
Percentage of participants with Metabolic dysfunction-associated steatotic liver disease (MASLD)
Time frame: 2021-2026
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Derived from this study: PubMed 38047735Wang G, Zhao Y, Li Z, Li D, Zhao F, Hao J, Yang C, Song J, Gu X, Huang R. Association between novel inflammatory markers and non-alcoholic fatty liver disease: a cross-sectional study. Eur J Gastroenterol Hepatol. 2024 Feb 1;36(2):203-209. doi: 10.1097/MEG.0000000000002686. Epub 2023 Dec 1.
- 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.
Rongchong Huang, M.D. principal investigator
Beijing Friendship Hospital
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 Obesity and Hypertension, run by Beijing Friendship Hospital at 1 site in China.
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 4 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: status not confirmed, as of the sponsor's last update on 2 Oct 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with major adverse cardiovascular events (MACEs) (time frame: 2021-2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05156580, which also lists 1 linked publication.
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 2 Oct 2025.