Evaluating the Effects of Electroacupuncture and Rosiglitazone Combined Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01577095|
Recruitment Status : Completed
First Posted : April 13, 2012
Last Update Posted : April 13, 2012
Aims: To evaluate the efficacy of rosiglitazone (TZD) and electroacupuncture (EA) combined therapy on patients with type 2 diabetes mellitus (T2DM). A randomized single-blind placebo controlled clinical trial was used.
Methods: A total of 31 newly diagnostic type 2 diabetic patients, who fulfilled the eligibility criteria were recruited and received various allocated interventions. They were randomly assigned into two groups, the control group (TZD, N=15) and the experimental group (TZD + EA, N=16). Changes in their plasma free fatty acid (FFA), glucose and insulin levels together with their homeostasis model assessment (HOMA) indices were statistically assessed between before and after treatment. Hypoglycemic activity (%) was also compared between these two groups.
Expecting Results: This study will compare the hypoglycemic activity and the ability of improving insulin resistance between the TZD and TZD+EA group. Also, the lowering effect of the plasma FFA concentration will be investigated.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus With Features of Insulin Resistance||Other: EA + Rosiglitazone Drug: TZD||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized Controlled Trial Evaluating the Effects of Electroacupuncture and Rosiglitazone Combined Therapy on Patients With Type 2 Diabetes Mellitus|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||May 2007|
|Actual Study Completion Date :||May 2007|
|Experimental: EA + Rosiglitazone||
Other: EA + Rosiglitazone
electroacupuncture and Rosiglitazone combined therapy on patient of type II DM
Other Name: Electroacupuncture and Rosiglitazone combined therapy
|Placebo Comparator: Rosiglitazone||
Rosiglitazone 8 mg single dose
Other Name: The effect of hypoglycemia and improving insulin sensitivity
- plasma glucose [ Time Frame: Time point(s) at which outcome measure is assessed in one year ]The primary endpoint with respect to plasma glucose level after treatment in each group of patients and compare the hypoglycemic activity between these two independent groups.
- plasma free fatty acid (FFA) [ Time Frame: Time point(s) at which outcome measure is assessed in one year. ]This secondary endpoint will compare the percent change of plasma FFA level between these two independent groups.
- plasma insulin [ Time Frame: Time point(s) at which outcome measure is assessed in one yease ]This secondary endpoint will compare the plasma insulin level after treatment of each group and the change between these two independent groups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01577095
|Department of Integrative Chinese-Western Clinic, China Medical University Hospital|
|Taichung, Taiwan, 404|
|Principal Investigator:||Shih-Liang Chang, PhD||China Medical University, China|