Evaluating the Effects of Electroacupuncture and Rosiglitazone Combined Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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This study is compared the effect between combined therapy (EA+TZD) and drug (TZD) on the patient of type 2 DM.

Official Title
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A Randomized Controlled Trial Evaluating the Effects of Electroacupuncture and Rosiglitazone Combined Therapy on Patients With Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes Mellitus With Features of Insulin Resistance

Intervention / Treatment
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* Other: EA + Rosiglitazone
* Drug: TZD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all included native Taiwanese patients, age from 20 to 65 years who diagnosed with type 2 diabetes mellitus within 5 years and keep the same anti-hyperglycemic agents for control diabetes before and during the period in this study compatible with the diagnostic criteria of diabetes mellitus according to American Diabetes Association Exclusion Criteria: individuals with nephrotic syndrome (urine protein over 3.5 g/day) and edema or renal failure (serum creatinine over 115 μmol/L) individuals who were diagnosed of heart failure (NYHA Fc III IV) or pacemaker implantation individuals with abnormal liver function (GOT and GPT level above 2 folds of normal range) or diagnosis of liver cirrhosis individuals with higher HbA1C level (HbA1C above 9%) pregnant women individuals who were receiving the classes of drugs thiazolidinediones already individuals who were receiving insulin therapy already individuals who were receiving other therapy during the period of study individuals suffering a homeostasis disorder or other systemic disease individuals who did not comply with the treatment during the study period

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EA + Rosiglitazone<br> | Other: EA + Rosiglitazone<br>* electroacupuncture and Rosiglitazone combined therapy on patient of type II DM<br>* Other names: Electroacupuncture and Rosiglitazone combined therapy;|
| Placebo Comparator: Rosiglitazone<br> | Drug: TZD<br>* Rosiglitazone 8 mg single dose<br>* Other names: The effect of hypoglycemia and improving insulin sensitivity;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma glucose | 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. | Time point(s) at which outcome measure is assessed in one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma free fatty acid (FFA) | This secondary endpoint will compare the percent change of plasma FFA level between these two independent groups. | Time point(s) at which outcome measure is assessed in one year. | 
| plasma insulin | This secondary endpoint will compare the plasma insulin level after treatment of each group and the change between these two independent groups. | Time point(s) at which outcome measure is assessed in one yease | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electroacupuncture, rosiglitazone, plasma glucose, insulin resistance, free fatty acid