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Improvement of Insulin Resistance With Traditional Chinese Treatment in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT00704236
First received: June 16, 2008
Last updated: December 10, 2008
Last verified: December 2008
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase 4 Study on the Effect of Insulin Resistance With Traditional Chinese Treatment in Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

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
Experimental: A 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
Placebo Comparator: B Drug: Placebo

  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

  1. Those patients used any drugs for treatment of diabetes
  2. Patients with evidence of cardiac, hepatic, renal, other chronic diseases or acute diabetic complications including diabetic ketoacidosis or hyperosmolar hyperglycemic non-ketotic coma
  3. Women who were pregnant or planned pregnant.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00704236

Locations
China, Shanghai
Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai, China, 200025
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Guang Ning, MD. PHD Shanghai Jiao Tong University School of Medicine
  More Information

No publications provided

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

Keywords provided by Shanghai Jiao Tong University School of Medicine:
Traditional Chinese Treatment

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism

ClinicalTrials.gov processed this record on May 16, 2013