- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01577095
Evaluating the Effects of Electroacupuncture and Rosiglitazone Combined Therapy
A Randomized Controlled Trial Evaluating the Effects of Electroacupuncture and Rosiglitazone Combined Therapy on Patients With Type 2 Diabetes Mellitus
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Taichung, Taiwan, 404
- Department of Integrative Chinese-Western Clinic, China Medical University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EA + Rosiglitazone
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electroacupuncture and Rosiglitazone combined therapy on patient of type II DM
Other Names:
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Placebo Comparator: Rosiglitazone
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Rosiglitazone 8 mg single dose
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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)
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.
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Time point(s) at which outcome measure is assessed in one year.
|
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.
|
Time point(s) at which outcome measure is assessed in one yease
|
Collaborators and Investigators
Investigators
- Principal Investigator: Shih-Liang Chang, PhD, China Medical University, China
Publications and helpful links
General Publications
- 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.
- Lin RT, Pai HC, Lee YC, Tzeng CY, Chang CH, Hung PH, Chen YI, Hsu TH, Tsai CC, Lin JG, Chang SL. Electroacupuncture and rosiglitazone combined therapy as a means of treating insulin resistance and type 2 diabetes mellitus: a randomized controlled trial. Evid Based Complement Alternat Med. 2013;2013:969824. doi: 10.1155/2013/969824. Epub 2013 Jul 29.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DMR94-IRB-139
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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