Completed

Berberine for Type 2 Diabetes and Dyslipidemia Treatment

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

This phase 3 study aims to evaluate the effectiveness of Berberine in treating type 2 diabetes and dyslipidemia, by observing its impact on your fasting glucose levels, HbA1c, HDL-c, LDL-c, OGTT 2h glucose levels, serum total cholesterol, and serum triglycerides.

What is being tested

Data Collection

Who is being recruted

Diabetes Mellitus+8

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 25 to 70 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: April 2005
See protocol details

Summary

Principal SponsorShanghai Jiao Tong University School of Medicine
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2005

Actual date on which the first participant was enrolled.

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.

Official TitleThe Efficacy and Safety of Berberine in the Treatment of Type 2 Diabetes With Dyslipidemia
NCT00462046
Principal SponsorShanghai Jiao Tong University School of Medicine
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 25 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesHyperinsulinismInsulin ResistanceMetabolic DiseasesNutritional and Metabolic DiseasesMetabolic SyndromeGlucose Metabolism DisordersDyslipidemiasLipid Metabolism Disorders

Criteria

4 inclusion criteria required to participate
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.

6 exclusion criteria prevent from participating
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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers
Berberine for Type 2 Diabetes and Dyslipidemia Treatment | PatLynk