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