Type 2 Diabetes Mellitus With Features of Insulin Resistance Clinical Trial
Official title:
A Randomized Controlled Trial Evaluating the Effects of Electroacupuncture and Rosiglitazone Combined Therapy on Patients With Type 2 Diabetes Mellitus
| Verified date | April 2012 |
| Source | China Medical University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Taiwan: Department of Health |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 49 |
| Est. completion date | May 2007 |
| Est. primary completion date | May 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | Department of Integrative Chinese-Western Clinic, China Medical University Hospital | Taichung |
| Lead Sponsor | Collaborator |
|---|---|
| China Medical University Hospital |
Taiwan,
Pai HC, Tzeng CY, Lee YC, Chang CH, Lin JG, Cheng JT, Chang SL. Increase in plasma glucose lowering action of rosiglitazone by electroacupuncture at bilateral Zusanli acupoints (ST.36) in rats. J Acupunct Meridian Stud. 2009 Jun;2(2):147-51. doi: 10.1016/S2005-2901(09)60047-9. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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. | No |
| Secondary | 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 | No |
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