NCT00462046

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, 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at below P25 for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started Apr 2005

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 18, 2007

Completed
Last Updated

April 18, 2007

Status Verified

April 1, 2007

First QC Date

April 16, 2007

Last Update Submit

April 16, 2007

Conditions

Diabetes Mellitus, Type 2Metabolic Syndrome

Keywords

BerberineType 2 diabetesDyslipidemia

Outcome Measures

Primary Outcomes (7)

  • Fasting glucose levels

  • OGTT 2h glucose levels

  • HbA1c

  • Serum Triglycerides

  • Serum Total Cholesterol

  • HDL-c

  • LDL-c

Secondary Outcomes (3)

  • Glucose Disposal Rate

  • BMI

  • Blood pressure

Interventions

BerberineDRUG

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Metabolic SyndromeDyslipidemias

Interventions

Berberine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesInsulin ResistanceHyperinsulinismLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Berberine AlkaloidsBenzylisoquinolinesAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-Ring

Study Officials

  • Xiao-Ying Li, MD,PhD

    Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 16, 2007

First Posted

April 18, 2007

Study Start

April 1, 2005

Study Completion

September 1, 2006

Last Updated

April 18, 2007

Record last verified: 2007-04