Type 2 Diabetes Mellitus With Features of Insulin Resistance
Conditions
Keywords
electroacupuncture, rosiglitazone, plasma glucose, insulin resistance, free fatty acid
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.
Interventions
OTHEREA + Rosiglitazone
electroacupuncture and Rosiglitazone combined therapy on patient of type II DM
DRUGTZD
Rosiglitazone 8 mg single dose
Sponsors
China Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| plasma glucose | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| plasma free fatty acid (FFA) | 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. |
| plasma insulin | 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. |
Countries
Taiwan
Outcome results
None listed