Overview

Evaluating the Effects of Electroacupuncture and Rosiglitazone Combined Therapy

Status:
Completed
Trial end date:
2007-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
China Medical University Hospital
Treatments:
Insulin
Rosiglitazone
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