Obesity
Conditions
Interventions
Sponsors
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Age 18-65 years; 2) BMI = 28.0 kg/m²; 3) Willing to participate in the study and sign the informed consent form; 4) Accept collection of information related to the four diagnoses of Traditional Chinese Medicine (TCM), TCM constitution classification, and TCM syndrome identification; 5) Have the ability and willingness for a 2-year follow-up and be able to complete follow-up arrangements on time.
Exclusion criteria
Exclusion criteria: 1) Females who are currently pregnant, lactating, or planning a pregnancy within the next 2 years; 2) Individuals with acute or chronic viral hepatitis, tuberculosis, malignant tumors, severe liver dysfunction, or chronic kidney disease who are receiving ongoing pharmacotherapy; 3) History of severe cardiovascular or cerebrovascular events within the past 6 months (such as acute myocardial infarction or stroke); 4) Comorbid chronic conditions, including but not limited to: hyperthyroidism, hypothyroidism, gastrointestinal diseases (e.g., peptic ulcer bleeding, gastroesophageal reflux disease, colitis, history of gastrointestinal surgery); 5) Secondary obesity caused by endocrine disorders, such as abnormal cortisol secretion; 6) Use of medications affecting hormonal levels (such as hydrocortisone, prednisone, and dexamethasone); 7) Use of weight-affecting or glucose-lowering drugs within 3 months prior to screening, including but not limited to: antidepressants, herbal medicines, metformin, GLP-1 receptor agonists, SGLT-2 inhibitors, and levothyroxine; 8) Current uncontrolled psychiatric disorders or regular use of antidepressants/antiepileptic drugs; 9) Participants in other clinical trials within the past 4 weeks; 10) Other conditions deemed unsuitable for participation in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body Mass Index (BMI);Body composition analysis of Inbody;Fasting blood glucose;Insulin resistance index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Anthropometric Parameters: Height, Weight, Waist Circumference, Hip Circumference, Waist-to-Height Ratio, Waist-to-Hip Ratio, and Blood Pressure;2-Hour postprandial blood glucose;Glycated hemoglobin;Fasting insulin;2-Hour postprandial insulin;Total cholesterol;Triglyceride;Low density lipoprotein cholesterin;High density lipoprotein cholesterol;High sensitivity C-reactive protein;Serum creatinine;Serum urea nitrogen;Blood uric acid;Glomerular filtration rate;Alanine aminotransferase;Aspartate aminotransferase;?-glutamyl transpeptidase;Alkaline phosphatase;Total bilirubin;Blood routine examination;Urine pregnancy test;Routine urine test;electrocardiograms;Carotid artery ultrasound;Multi-omics Data Collection: Serum O-link proteomics, Serum energy metabolomics, Serum targeted lipidomics, Metagenomic sequencing of gut microbes, Urine metabolism;Collection of Traditional Chinese Medicine phenotype: the picture of Tongue;Physical fitness scale of traditional Chinese medicine;Traditional Chinese Medicine syndrome investigation scale of obesity;Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT);Short Form 36 Health Survey (SF-36); | — |
Countries
China
Contacts
Public ContactHao Lu
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed