Evaluating the Effects of Electroacupuncture and Rosiglitazone Combined Therapy
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.
|Type 2 Diabetes Mellitus With Features of Insulin Resistance||Other: EA + Rosiglitazone Drug: TZD||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
|Official Title:||A Randomized Controlled Trial Evaluating the Effects of Electroacupuncture and Rosiglitazone Combined Therapy on Patients With Type 2 Diabetes Mellitus|
- 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.
|Study Start Date:||April 2006|
|Study Completion Date:||May 2007|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
|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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01577095
|Department of Integrative Chinese-Western Clinic, China Medical University Hospital|
|Taichung, Taiwan, 404|
|Principal Investigator:||Shih-Liang Chang, PhD||China Medical University, China|