Metabolic syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.20-65 years old; 2. The diagnostic criteria of metabolic syndrome (MS) refer to the Chinese Guidelines for the Prevention and Treatment of Type 2 diabetes (2020), and the following three or more items can be diagnosed: Abdominal obesity (i.e. central obesity): Waist circumference>90cm for males and = 85cm for females. Hyperglycemia: fasting blood glucose = 6.1 mmol/L or blood glucose = 7.8 mmol/L 2h after glucose load and (or) diagnosed with diabetes and treated. Hypertension: Patients with blood pressure = 130/85mmHg (1mmHg=0.133kPa) and/or confirmed hypertension and treated. Fasting triglycerides (TG) = 1.70mmol/L. Fasting HDL-C<1.04 mmol/L. The waist circumference cutoff point for central obesity is based on the standards established by the 2013 National Health and Family Planning Commission's "Health Industry Standard of the People's Republic of China - Adult Weight Determination" (standard number WS/T428-2013). 3. Agree to receive dietary control guidance and improve lifestyle during the trial period; When screening, women of childbearing age (those who have not undergone surgical sterilization or those who have been postmenopausal for less than 1 year) have negative pregnancy test results and are non lactating women. Agree to use effective contraceptive measures throughout the entire study period; 5. Voluntarily sign a written informed consent form, able to maintain good communication with researchers and comply with various requirements of clinical trials.
Exclusion criteria
Exclusion criteria: 1. Blood lipid abnormalities caused by secondary causes, such as nephrotic syndrome, hypothyroidism, renal failure, systemic lupus erythematosus, glycogen accumulation, myeloma, fatty atrophy, acute porphyria, and drug related factors (such as diuretics, glucocorticoids, etc.); 2. Any surgical or medical condition that may seriously affect the absorption, distribution, metabolism, or excretion of drugs: a history of major gastrointestinal surgeries, such as gastrectomy, gastrointestinal anastomosis, or intestinal resection; B Current active or recurrent irritable bowel syndrome (IBS) or inflammatory bowel disease (excluding those with a history of IBS but no symptoms for at least 6 months before screening visit); Current active gastritis, active ulcer, gastrointestinal bleeding; History of pancreatic or gallbladder diseases (excluding patients with gallbladder diseases who have previously undergone cholecystectomy); 3. Body mass index (BMI) = 35 kg/m2. 4. History of chronic liver disease or cirrhosis; 5. Patients with the following medical history within 6 months before screening visit: acute coronary syndrome (ACS), coronary revascularization, congestive heart failure (NYHA classification>Grade II), cerebrovascular accident (including TIA), severe peripheral atherosclerosis, cardiovascular surgery or major surgery; 6. Poor control of hypertension, with diastolic blood pressure>100mmHg and/or systolic blood pressure>160 mmHg; 7. diabetes and the condition meets any of the following conditions: type 1 diabetes, history of diabetes ketoacidosis, uncontrolled type 2 diabetes [defined as glycosylated hemoglobin (HbA1c)>9%; 8. Drug abusers or alcoholics [defined as drinking alcohol containing 14 units or more per week on average in the first three months of screening (1 unit=350 mL of beer, or 45 mL of Baijiu, or 150 mL of wine)]; 9. Have received any other investigational drug treatment or participated in another interventional clinical trial within 3 months prior to the screening visit; 10. In other cases, the researcher has determined that it is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fat distribution;VO2 max;maximal heart rate;anaerobic threshold;heart rate recovery; | — |
Secondary
| Measure | Time frame |
|---|---|
| lipid profile; Fasting blood glucose;glycosylated hemoglobin;insulin resistance index;The 36-item Short-Form Health Survey; | — |
Countries
China
Contacts
Shanghai Municipal Hospital of Traditional Chinese Medicine