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

This study has been completed.
Study NCT00704236.   Last updated on June 23, 2008.   Information provided by Shanghai Jiao Tong University of Medicine

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Descriptive Information Fields
Brief Title † Improvement of Insulin Resistance With Traditional Chinese Treatment in Patients With Type 2 Diabetes
Official Title † Phase 4 Study on the Effect of Insulin Resistance With Traditional Chinese Treatment in Type 2 Diabetes
Brief Summary

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
Detailed Description
Study Phase Phase IV
Study Type † Interventional
Study Design † Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure † Glucose Disposal Rate
Secondary Outcome Measure † Fasting Plasma Glucose,Postprandial Plasma Glucose,HbA1c,triglyceride,cholesterol,HDL-c and LDL-c,lipid levels ,body weight, blood pressure
Condition † Type 2 Diabetes
Intervention † Drug: Coptis Chinensis, Astragalus mambranesceus, Lonicera Japonica (Traditional Chinese Treatment)
Drug: Placebo
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status † Completed
Enrollment † 43
Start Date † September 2006
Completion Date February 2008
Eligibility 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.
Gender Both
Ages 18 Years to 70 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries † China
Administrative Information Fields
NCT ID † NCT00704236
Organization ID CCEMD003
Secondary IDs ††
Study Sponsor † Shanghai Jiao Tong University of Medicine
Collaborators ††
Investigators †
Principal Investigator:     Guang Ning, MD. PHD     Shanghai Jiao Tong University, School of Medicine    
Information Provided By Shanghai Jiao Tong University of Medicine
Verification Date June 2008
First Received Date † June 16, 2008
Last Updated Date June 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.

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