Obesity and OverweightNCT06673433
The Effects of Environmental Factors on the Macro-genome and Metabolism of Obese Patients.
An observational study of Obesity and Overweight, run by Dong Peng at 1 site in China.
Trial summary
The present study was designed to include obese patients diagnosed with obesity in the First Affiliated Hospital of Chongqing Medical University and a healthy control population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity and Overweight
- What is being tested?
- obesity and health
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 1 Dec 2025
- 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: This study intend to include patients diagnosed with obesity in the First Hospital of Chongqing Medical University.
Who may be able to join
- Age ≥18 years;
- Obese patients with BMI ≥30kg/m2;
- Patients did not undergo surgical treatment before enrolment;
- Willing to participate in this study and sign the informed consent form;
- Complete clinical data.
Who cannot join
- Patients with systemic diseases such as severe cardiorespiratory insufficiency that affect the choice of treatment regimen;
- Pregnant or lactating women;
- Patients who are not suitable for enrolment as assessed by the investigator;
- Patients with incomplete clinical data.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
About this study
Official title: The Effect of Environmental Factors on the Macro-genome and Metabolism of Obese Patients.
The present study was designed to include obese patients diagnosed with obesity in the First Affiliated Hospital of Chongqing Medical University and a healthy control population. By analysing the relationship between metabolic parameters and macrogenomes in obesity, identifying key metabolic and macrogenomic differences between obese patients and healthy populations, and establishing the association between environmental factors and obesity-related metabolic disorders, the investigators will be able to provide new biomarkers and intervention targets for obesity prevention and treatment.
Read the detailed description
Obese patients who attended the First Hospital of Chongqing Medical University and intended to undergo bariatric surgery were screened according to the inclusion and exclusion criteria. Patients' basic personal information and biological specimens including blood, faeces and urine were collected for metabolic and macro-genomic analyses. Air pollution exposure of the study subjects was collected by telephone follow-up. Metabolite profiles in blood and urine were analysed using liquid chromatography-mass spectrometry (LC-MS). Microbial community composition in faecal samples was analysed using 16S rRNA gene sequencing. Metabolic and macrogenomic differences between obese and control groups were compared using t-test or Mann-Whitney U-test. Logistic regression analyses were used to assess the independent effects of different environmental factors on metabolism and macrogenome. Identify key metabolites and microorganisms associated with obesity using Random Forest and Principal Component Analysis.
- Conditions
- Obesity and Overweight
- Being tested
- obesity, health
- Keywords
- obesity, environment, air pollution, macrogenomics, metabolism
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
obesityDiagnostic test
Patients diagnosed with obesity (BMI ≥ 28kg/m2)
healthDiagnostic test
the health control group include paticipants with nomal BMI
| Study group | Role | What they receive |
|---|---|---|
| the obesity group | Patients diagnosed with obesity (body mass index (BMI) ≥ 28kg/m2) Receives: Diagnostic Test: obesity | |
| the control group | Paticipants with nomal BMI （18.5 - 24 kg/m2) Receives: Diagnostic Test: health |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
BMI = weight / height squared (kg/m2)
Measured: BMI was examed when first join the study, whith through the whole study period, an average of 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start1 Oct 2022
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong Peng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dong Peng, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673433
- Sponsor's protocol ID
- 202-331-01
- Status last verified
- Nov 2024
- First submitted
- 2 Nov 2024
- Last updated
- 2 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Ethics Committee of this Clinical Centre does not allow the disclosure of patient information.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Environmental Factors on the Macro-genome and Metabolism of Obese Patients.
- ClinicalTrials.gov ID
- NCT06673433
- Acronym / sponsor ID
- 202-331-01
- Conditions
- Obesity and Overweight
- Keywords
- obesity, environment, air pollution, macrogenomics, metabolism
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Dong PengUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 4 Nov 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.
The present study was designed to include obese patients diagnosed with obesity in the First Affiliated Hospital of Chongqing Medical University and a healthy control population. By analysing the relationship between metabolic parameters and macrogenomes in obesity, identifying key metabolic and macrogenomic differences between obese patients and healthy populations, and establishing the association between environmental factors and obesity-related metabolic disorders, the investigators will be able to provide new biomarkers and intervention targets for obesity prevention and treatment.
Detailed description
Obese patients who attended the First Hospital of Chongqing Medical University and intended to undergo bariatric surgery were screened according to the inclusion and exclusion criteria. Patients' basic personal information and biological specimens including blood, faeces and urine were collected for metabolic and macro-genomic analyses. Air pollution exposure of the study subjects was collected by telephone follow-up. Metabolite profiles in blood and urine were analysed using liquid chromatography-mass spectrometry (LC-MS). Microbial community composition in faecal samples was analysed using 16S rRNA gene sequencing. Metabolic and macrogenomic differences between obese and control groups were compared using t-test or Mann-Whitney U-test. Logistic regression analyses were used to assess the independent effects of different environmental factors on metabolism and macrogenome. Identify key metabolites and microorganisms associated with obesity using Random Forest and Principal Component Analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the obesity group | – | Diagnostic Test: obesityPatients diagnosed with obesity (body mass index (BMI) ≥ 28kg/m2) |
| the control group | – | Diagnostic Test: healthPaticipants with nomal BMI （18.5 - 24 kg/m2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study intend to include patients diagnosed with obesity in the First Hospital of Chongqing Medical University.
Key inclusion criteria (5 listed)
- Age ≥18 years;
- Obese patients with BMI ≥30kg/m2;
- Patients did not undergo surgical treatment before enrolment;
- Willing to participate in this study and sign the informed consent form;
- Complete clinical data.
Key exclusion criteria (4 listed)
- Patients with systemic diseases such as severe cardiorespiratory insufficiency that affect the choice of treatment regimen;
- Pregnant or lactating women;
- Patients who are not suitable for enrolment as assessed by the investigator;
- Patients with incomplete clinical data.
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 |
|---|---|---|
| obesityPatients diagnosed with obesity (BMI ≥ 28kg/m2) | Diagnostic test | the obesity group |
| healththe health control group include paticipants with nomal BMI | Diagnostic test | the control group |
Primary outcome
BMI
Time frame: BMI was examed when first join the study, whith through the whole study period, an average of 1 month.
BMI = weight / height squared (kg/m2)
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 2 Jun 2025.
- Individual participant dataSharing planned: No. The Ethics Committee of this Clinical Centre does not allow the disclosure of patient information.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Overweight, run by Dong Peng 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 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: under way, not looking for participants, as of the sponsor's last update on 2 Jun 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?
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?
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?
BMI (time frame: BMI was examed when first join the study, whith through the whole study period, an average of 1 month.). 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 2 Jun 2025.