[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100447352":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":44,"responsibleParty":59,"collaborators":63,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":33,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":90,"whyStopped":33,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Peking University Third Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo Group","PLACEBO_COMPARATOR","Placebo plus healthy lifestyle intervention. Placebo with same appearance of berberine tablet will be orally taken twice daily and maintained until the last subject completes 3-year intervention.",[13],"Behavioral: Healthy lifestyle intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Berberine Group","EXPERIMENTAL","Berberine plus healthy lifestyle intervention. Berberine dose is 500mg twice daily and maintained until the last subject completes 3-year intervention.",[19,13],"Drug: Berberine",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Berberine","The tablet of berberine and placebo are both coated with white sugar and had the same appearance. Berberine tablet will be orally taken with a dose of 500mg twice daily",[15],[27],"berberine hydrochloride",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"BEHAVIORAL","Healthy lifestyle intervention","Healthy lifestyle intervention will be launched according to the \"Chinese guidelines on prevention of cardiovascular and metabolic diseases by Chinese Preventive Medical Association in 2019\", including health lectures, health information promotion, health manual and so on.",[15,9],null,[35],{"name":36,"affiliation":5,"role":37},"Yi-Da Tang, MD, PhD","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":33,"email":43},"Wenyao Wang, MD, PhD","CONTACT","0086-18810488381","wwypumc@126.com",[45],{"facility":5,"status":33,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Beijing","Beijing Municipality","100191","China","CN",{"type":52,"coordinates":53},"Point",[54,55],116.39723,39.9075,{"lat":55,"lon":54},[58],{"name":40,"role":41,"phone":33,"phoneExt":33,"email":33},{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"SPONSOR_INVESTIGATOR","Tang Yida","Chief-Cardiologist and Director",[64],{"name":65,"class":6},"Chinese Society of Cardiology","100447352","phase-4-cardiovascular-diseases-and-diabetes-prevention-programme-in-metabolic-syndrome-cdpp-100447352",false,"NCT05105321","Cardiovascular Diseases and Diabetes Prevention Programme in Metabolic Syndrome (CDPP)","Efficacy and Safety of Berberine on Primary Prevention of Cardiovascular Diseases and Diabetes in Metabolic Syndrome: a Randomized, Controlled Trial","CDPP","Inclusion Criteria:\n\n* Patients diagnosed with metabolic syndrome aged 40-75 years old.\n* Metabolic syndrome was defined according to the Chinese Guidelines for the Prevention and Treatment of Dyslipidemia in Adults (revised edition 2016). Subjects will be diagnosed with metabolic syndrome when meeting three or more of the following items: 1, central obesity and\u002For abdominal obesity (waist circumference ≥90cm for men and ≥ 85cm for women); 2, hyperglycemia (fasting blood glucose ≥6.10 mmol\u002FL or two-hour blood glucose ≥7.80 mmol\u002FL in glucose tolerance test); 3, hypertension: blood pressure ≥130\u002F85 mmHg and\u002For diagnosed hypertension under treatment; 4, fasting triglyceride ≥1.7 mmol\u002FL (150mg\u002Fdl); 5, fasting HDL cholesterol\\\u003C1.0 mmol\u002FL.\n\nExclusion Criteria:\n\n* Previously diagnosed diabetes.\n* Baseline LDL cholesterol≥130mg\u002Fdl (3.4mmol\u002FL).\n* Baseline triglyceride≥500mg\u002Fdl (5.6mmol\u002FL).\n* Baseline blood pressure ≥140\u002F90 mmHg (twice not on the same day).\n* Impaired liver function, have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, alanine\u002Faspartate aminotransferase levels \\>3 times the upper limit of the reference range at the screening visit.\n* Renal dysfunction (glomerular filtration rate\\\u003C45ml\u002Fmin)\n* Patients ventilated by ventilator.\n* Hypersensitivity to berberine.\n* Disease which may cause tissue hypoxia (especially acute disease, or worsening of chronic respiratory disease).\n* Severe chronic gastrointestinal disease.\n* Severe psychiatric illness.\n* Cancer requiring treatment in past 5 years.\n* Women who are pregnant or breastfeeding .\n* Participation in another clinical trial within the past 30 days .\n* Other significant disease that in the Investigator's opinion would exclude the subject from the trial.","ALL","40 Years","75 Years",{"count":78,"type":79},5200,"ESTIMATED","INTERVENTIONAL",[82],"PHASE4","The metabolic syndrome population is at high-risk of cardiovascular diseases and diabetes. How to effectively control the risk factors of this population is the key to primary prevention of cardiovascular diseases and diabetes in China. This study aims to explore the efficacy and safety of an intervention strategy with berberine that can effectively treat a variety of risk factors (hyperglycemia, dyslipidemia, hypertension).",[85],"Metabolic Syndrome",[23,87,88,85,89],"Cardiovascular Diseases","Diabetes","Primary Prevention","NOT_YET_RECRUITING","2021-11-01",{"date":93,"type":94},"2021-11-03","ACTUAL",{"date":96,"type":79},"2021-12",{"date":98,"type":79},"2028-12",{"name":61,"class":6},1]