The Effects of Environmental Factors on the Macro-genome and Metabolism of Obese Patients.

NCT06673433 — Active not recruiting, 300 participants, Dong Peng

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The Effect of Environmental Factors on the Macro-genome and Metabolism of Obese Patients.

Registry	NCT06673433
Status	Active not recruiting
Study type	Observational
Enrollment	300 (Estimated)
Sponsor	Dong Peng (Other)
Conditions	Obesity and Overweight
Interventions	obesity, health (Diagnostic test)
Dates	start 2022-10-01, primary completion 2025-08-01 (estimated), completion 2025-12-01 (estimated), first posted 2024-11-04, last updated 2025-06-02
Locations	1 site in China

-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. 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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
the obesity group		Diagnostic Test: obesity	Patients diagnosed with obesity (body mass index (BMI) ≥ 28kg/m2)
the control group		Diagnostic Test: health	Paticipants with nomal BMI （18.5 - 24 kg/m2)

obesity (Diagnostic test): Patients diagnosed with obesity (BMI ≥ 28kg/m2)
health (Diagnostic test): the health control group include paticipants with nomal BMI

+Outcome measures

Primary outcomes

BMI [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)

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

+Locations (1)

Facility	City	Country	Status
The First Affiliated Hospital of Chongqing Medical University	Chongqing, Chongqing Municipality	China