Improvement of Insulin Resistance With Traditional Chinese Treatment in Patients With Type 2 Diabetes - Full Text View

Sponsored by:	Shanghai Jiao Tong University of Medicine
Information provided by:	Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:	NCT00704236

Purpose

The purpose of this study is to evaluate the efficacy of Traditional Chinese Treatment(TCT) on insulin sensitivity and other related factors in type 2 diabetes by using an double-blind, randomized, parallel control and prospective study This traditional compound Chinese herb preparation is referred to this study, with three kinds of plants: 50 mg of Coptis Chinensis, 30 mg of Astragalus mambranesceus and 120 mg of Lonicera Japonica, all of which are selected by The Chinese Academy of Medical Sciences among those traditionally considered effective and safe in the treatment of diabetes.

Patients enrolled were randomized into TCT group and placebo group administrated with TCT and placebo respectively. Glucose disposal rate (GDR), fasting plasma glucose (FPG), postprandial plasma glucose (PPG), HbA1C and other metabolic components were assessed at baseline and end point

Condition	Intervention	Phase
Type 2 Diabetes	Drug: Coptis Chinensis, Astragalus mambranesceus, Lonicera Japonica (Traditional Chinese Treatment) Drug: Placebo	Phase IV

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase 4 Study on the Effect of Insulin Resistance With Traditional Chinese Treatment in Type 2 Diabetes

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

Primary Outcome Measures:

Glucose Disposal Rate

Secondary Outcome Measures:

Fasting Plasma Glucose,Postprandial Plasma Glucose,HbA1c,triglyceride,cholesterol,HDL-c and LDL-c,lipid levels ,body weight, blood pressure

Enrollment:	43
Study Start Date:	September 2006
Study Completion Date:	February 2008

Arms	Assigned Interventions
A: Experimental	Drug: Coptis Chinensis, Astragalus mambranesceus, Lonicera Japonica (Traditional Chinese Treatment) 50 mg of Coptis Chinensis, 30 mg of Astragalus mambranesceus and 120 mg of Lonicera Japonica
B: Placebo Comparator	Drug: Placebo

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Newly diagnosed type 2 diabetes poorly controlled by diet only for one month
Obese with a BMI of 23-35 kg/m2

Exclusion Criteria:

Those patients used any drugs for treatment of diabetes
Patients with evidence of cardiac, hepatic, renal, other chronic diseases or acute diabetic complications including diabetic ketoacidosis or hyperosmolar hyperglycemic non-ketotic coma
Women who were pregnant or planned pregnant.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00704236

Locations

China
Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200025

Sponsors and Collaborators

Shanghai Jiao Tong University of Medicine

Investigators

Principal Investigator:

Guang Ning, MD. PHD

Shanghai Jiao Tong University School of Medicine

More Information

Study ID Numbers:	CCEMD003
Study First Received:	June 16, 2008
Last Updated:	December 10, 2008
ClinicalTrials.gov Identifier:	NCT00704236
Health Authority:	China: Ethics Committee

Keywords provided by Shanghai Jiao Tong University School of Medicine:

Traditional Chinese Treatment

Study placed in the following topic categories:

Hyperinsulinism
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Insulin Resistance
Metabolic disorder
Glucose Metabolism Disorders
Insulin

ClinicalTrials.gov processed this record on January 16, 2009