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Efficacy and Safety of Berberine in the Treatment of Diabetes With Dyslipidemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00462046
First Posted: April 18, 2007
Last Update Posted: April 18, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shanghai Jiao Tong University School of Medicine
  Purpose
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, placebo controlled and multi-center study has demonstrated that berberine is effective in lowering plasma glucose concentrations, reducing serum HbA1c and anti-dyslipidemia in type 2 diabetic patients with dyslipidemia.

Condition Intervention Phase
Diabetes Mellitus, Type 2 Metabolic Syndrome Drug: Berberine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Berberine in the Treatment of Type 2 Diabetes With Dyslipidemia

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • Fasting glucose levels
  • OGTT 2h glucose levels
  • HbA1c
  • Serum Triglycerides
  • Serum Total Cholesterol
  • HDL-c
  • LDL-c

Secondary Outcome Measures:
  • Glucose Disposal Rate
  • BMI
  • Blood pressure

Estimated Enrollment: 120
Study Start Date: April 2005
Study Completion Date: September 2006
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 treatment of type 2 diabetic patients with dyslipidemia. 116 patients with type 2 diabetes and dyslipidemia were assigned in a randomized, double-blind, and placebo-controlled 4-clinical center study to receive berberine (1.0g daily) or placebo for 3 months. The primary efficacy outcomes were changes in plasma glucose and serum lipid levels. The glucose disposal rate (GDR) was measured using a hyperinsulinemic euglycemic clamp to assess insulin resistance in a randomly selected subjects of 54 patients. The baseline characteristics were similar in berberine and placebo groups. After 3 months, fasting and post load plasma glucose levels, HbA1C, triglyceride, total cholesterol and LDL-C levels were all significantly reduced in the berberine group compared with the placebo group (p<0.0001, p<0.0001, p<0.0001, p=0.002, p<0.0001 and p<0.0001 respectively). The GDR was significantly increased after 3 months of berberine (p=0.037), while no change was found in the placebo group (p=0.86). BMI, systolic blood pressure and serum IL-6 levels were all significantly reduced after treatment in berberine group as compared with the placebo group (p=0.016, p=0.041 and p=0.014, respectively). Our results show berberine to be effective and safe in the treatment of persons with diabetes and dislipidemia. This agent may be useful in the treatment of patients with type 2 diabetes, and could play a role in treatment of metabolic syndrome.
  Eligibility

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age of 25 -70 years;
  2. Newly diagnosed type 2 diabetes according to the 1999 World Health Organization criteria;
  3. 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.
  4. BMI:19 – 40 kg/m2.

Exclusion Criteria:

  1. Moderate or severe liver or renal dysfunction, psychiatric disease or severe infection;
  2. Severe dysfunction of the heart,New York Heart Association class ³ Ⅲ phase;
  3. History of acute diabetic complications;
  4. Pregnancy or planned pregnancy.
  5. Present or previous use of drugs for treatment of diabetes or dyslipidemia;
  6. Fasting plasma glucose >8mmol/L and/or post load plasma glucose level >17mmol/L after 2-week run-in.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00462046


Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Xiao-Ying Li, MD,PhD Shanghai Jiao Tong University School of Medicine
  More Information

ClinicalTrials.gov Identifier: NCT00462046     History of Changes
Other Study ID Numbers: CCEMD001
First Submitted: April 16, 2007
First Posted: April 18, 2007
Last Update Posted: April 18, 2007
Last Verified: April 2007

Keywords provided by Shanghai Jiao Tong University School of Medicine:
Berberine
Type 2 diabetes
Dyslipidemia

Additional relevant MeSH terms:
Diabetes Mellitus
Metabolic Syndrome X
Diabetes Mellitus, Type 2
Dyslipidemias
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism
Lipid Metabolism Disorders