Clinical trial NCT06673433: The Effects of Environmental Factors on the Macro-genome and Metabolism of Obese Patients.
Official title: The Effect of Environmental Factors on the Macro-genome and Metabolism of Obese Patients.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Obesity and Overweight
Keywords: obesity
environment
air pollution
macrogenomics
metabolism
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study intend to include patients diagnosed with obesity in the First Hospital of Chongqing Medical University.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: BMI
timeFrame: BMI was examed when first join the study, whith through the whole study period, an average of 1 month.
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
References: