Berberine for Type 2 Diabetes and Dyslipidemia Treatment
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.
Data Collection
Diabetes Mellitus+8
+ Diabetes Mellitus, Type 2
+ Endocrine System Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.120 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives