Status:
COMPLETED
Efficacy and Safety of Berberine in the Treatment of Diabetes With Dyslipidemia
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Diabetes Mellitus, Type 2
Metabolic Syndrome
Eligibility:
All Genders
25-70 years
Phase:
PHASE3
Brief Summary
Berberine has showed effective in lowering blood sugar levels in db/db mice and anti-dyslipidemia in human. These findings have not been tested in a clinical trial. This randomized, double blind, plac...
Detailed Description
Berberine, a natural plant alkaloid, has not been well investigated for clinical application in the treatment of diabetes. The present study evaluated the efficacy and safety of berberine in the treat...
Eligibility Criteria
Inclusion
- Age of 25 -70 years;
- Newly diagnosed type 2 diabetes according to the 1999 World Health Organization criteria;
- Dyslipidemia with TG\> 150mg/dL (1.70mmol/L), and/or TC\>200mg/dL (5.16mmol/L), and/or LDL-C\>100mg/dL (2.58mmol/L) according to the National Cholesterol Education Program's Adult Treatment Panel III (NCEP: ATPIII) without previous treatment.
- BMI:19 - 40 kg/m2.
Exclusion
- Moderate or severe liver or renal dysfunction, psychiatric disease or severe infection;
- Severe dysfunction of the heart，New York Heart Association class ³ Ⅲ phase;
- History of acute diabetic complications;
- Pregnancy or planned pregnancy.
- Present or previous use of drugs for treatment of diabetes or dyslipidemia;
- Fasting plasma glucose \>8mmol/L and/or post load plasma glucose level \>17mmol/L after 2-week run-in.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00462046
Start Date
April 1 2005
End Date
September 1 2006
Last Update
April 18 2007
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