Evaluating the Effects of Electroacupuncture and Rosiglitazone Combined Therapy

China Medical University

Status and phase

Completed

Phase 2

Conditions

Type 2 Diabetes Mellitus With Features of Insulin Resistance

Treatments

Drug: TZD

Other: EA + Rosiglitazone

Study type

Interventional

Funder types

Other

Identifiers

NCT01577095

DMR94-IRB-139

Details and patient eligibility

About

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.

Full description

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

Enrollment

49 patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

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