Evaluating the Effects of Electroacupuncture and Rosiglitazone Combined Therapy

NCT ID: NCT01577095

Last Updated: 2012-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2007-05-31

Brief Summary

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

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

Conditions

Type 2 Diabetes Mellitus With Features of Insulin Resistance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

EA + Rosiglitazone

Group Type: EXPERIMENTAL

EA + Rosiglitazone

Intervention Type: OTHER

electroacupuncture and Rosiglitazone combined therapy on patient of type II DM

Rosiglitazone

Group Type: PLACEBO_COMPARATOR

TZD

Intervention Type: DRUG

Rosiglitazone 8 mg single dose

Interventions

EA + Rosiglitazone

electroacupuncture and Rosiglitazone combined therapy on patient of type II DM

Intervention Type: OTHER

TZD

Rosiglitazone 8 mg single dose

Intervention Type: DRUG

Other Intervention Names

Electroacupuncture and Rosiglitazone combined therapy; The effect of hypoglycemia and improving insulin sensitivity

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shih-Liang Chang, PhD

Role: PRINCIPAL_INVESTIGATOR

China Medical University, China

Locations

Department of Integrative Chinese-Western Clinic, China Medical University Hospital

Taichung, Taiwan, Taiwan

Countries

Taiwan

References

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.

Reference Type: BACKGROUND

PMID: 20633486 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23983807 (View on PubMed)

Other Identifiers

DMR94-IRB-139

Identifier Type: -

Identifier Source: org_study_id