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

April 16, 2007 updated by: Shanghai Jiao Tong University School of Medicine

The Efficacy and Safety of Berberine in the Treatment of Type 2 Diabetes With Dyslipidemia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

120

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
HbA1c
Fasting glucose levels
OGTT 2h glucose levels
Serum Triglycerides
Serum Total Cholesterol
HDL-c
LDL-c

Secondary Outcome Measures

Outcome Measure
Blood pressure
BMI
Glucose Disposal Rate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Xiao-Ying Li, MD,PhD, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

April 16, 2007

First Submitted That Met QC Criteria

April 16, 2007

First Posted (Estimate)

April 18, 2007

Study Record Updates

Last Update Posted (Estimate)

April 18, 2007

Last Update Submitted That Met QC Criteria

April 16, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCEMD001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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