Obesity
Conditions
Interventions
Sponsors
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1) Age: 18-65 years; 2) BMI = 28 kg/m² and < 37.5 kg/m²; 3) Meets the classification criteria for either Low-Metabolism Spleen Deficiency Phlegm-Dampness Type Obesity or High-Metabolism Spleen Deficiency Stasis-Heat Type Obesity; 4) Voluntarily participates and signs the informed consent form. High-Metabolism Spleen Deficiency Stasis-Heat Type Obesity: 1) Meets the criteria for abdominal obesity: male waist circumference = 90 cm, female waist circumference = 85 cm; 2) a. Hyperglycemia: Fasting blood glucose = 6.1 mmol/L or 2-hour post-load blood glucose = 7.8 mmol/L, and/or previously diagnosed with diabetes and under treatment; b. Hypertension: Blood pressure = 130/85 mmHg, and/or previously diagnosed with hypertension and under treatment; c. Fasting triglycerides = 1.70 mmol/L; d. Fasting HDL-C < 1.04 mmol/L; 3) Facial skin appears flushed, or dark, or dull red; or skin on the neck is rough and dark (acanthosis nigricans); 4) Loud voice; or aversion to heat with excessive sweating; or dry mouth, bitter taste; or irritability and restlessness; 5) Upper abdomen is large and feels resistant upon palpation; 6) Basal metabolic rate measured by Inbody Body Composition Analyzer is more than 10% higher than the theoretical basal metabolic rate calculated by the Harris-Benedict formula; 7) Tongue color: pale red, red, or dark red; enlarged tongue body; Pulse: wiry and slippery, wiry and rapid, slippery and rapid. Item 1) is mandatory; Item 2) meets at least 1 criterion; Items 3) to 6) meet at least 3 criteria, with reference to Item 7) for tongue and pulse signs. Low-Metabolism Spleen Deficiency Phlegm-Dampness Type Obesity: 1) Meets the criteria for abdominal obesity: male waist circumference = 90 cm, female waist circumference = 85 cm; 2) a. Hyperglycemia: Fasting blood glucose = 6.1 mmol/L or 2-hour post-load blood glucose = 7.8 mmol/L, and/or previously diagnosed with diabetes and under treatment; b. Hypertension: Blood pressure = 130/85 mmHg, and/or previously diagnosed with hypertension and under treatment; c. Fasting triglycerides = 1.70 mmol/L; d. Fasting HDL-C < 1.04 mmol/L; 3) Facial skin is sallow, with a puffy appearance and large eye bags; 4) Prefers stillness over movement and/or fatigue and lack of strength; or prone to sweating upon exertion; or frequent loose stools; 5) Abdominal obesity, with a large abdomen, excess flabby flesh, feels soft upon palpation; 6) Basal metabolic rate measured by Inbody Body Composition Analyzer is more than 10% lower than the theoretical basal metabolic rate calculated by the Harris-Benedict formula; 7) Tongue color: pale, pale dark; enlarged tongue body with tooth marks; Pulse: thready, deep and thready, thready and wiry and slippery. Item 1) is mandatory; Item 2) meets at least 1 criterion; Items 3) to 6) meet at least 3 criteria, with reference to Item 7) for tongue and pulse signs.
Exclusion criteria
Exclusion criteria: 1) Patients with diabetes: HbA1c =7%, or currently on Chinese or Western glucose-lowering medications; 2) Patients with hypertension: blood pressure remains =130/85 mmHg after regular medication; 3) Patients with other chronic diseases, such as hyperthyroidism, hypothyroidism, gastrointestinal disorders, cardiovascular and cerebrovascular diseases, etc.; 4) Secondary obesity due to other causes: abnormal cortisol secretion, etc.; 5) History of bariatric surgery, or plans to undergo bariatric surgery, liposuction, or other weight-loss procedures during the study period; 6) Use of medications affecting body weight or glucose-lowering drugs within the past 3 months before screening, including but not limited to: antidepressants, herbal medicines, metformin, GLP-1 receptor agonists, SGLT-2 inhibitors, etc.; 7) Women planning pregnancy, pregnant, or lactating; 8) Participation in other clinical trials within the past 4 weeks; 9) Known allergy or contraindications to the study interventions, or patients with a history of fainting during needle procedures; 10) Patients with bleeding or coagulation disorders, or those with infectious diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body Mass Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Body Weight ;Waist Circumference;Hip Circumference ;Waist-to-Hip Ratio;Body Fat Percentage;Fasting Blood Glucose ;Glycated Hemoglobin;Homeostatic Model Assessment of Insulin Resistance;Total Cholesterol;Triglycerides;High-Density Lipoprotein Cholesterol;Low-Density Lipoprotein Cholesterol;Tongue Diagnosis;Facial Diagnosis;TCM Syndrome Score;Serum O-Link Proteomics;Serum Metabolomics;Gut Microbiome Metagenomics;Food Craving Visual Analog Scale (FC-VAS) Score; | — |
Countries
China
Contacts
Public ContactGao tianshu
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Outcome results
None listed