Clinical trial NCT01577095: Evaluating the Effects of Electroacupuncture and Rosiglitazone Combined Therapy
Official title: A Randomized Controlled Trial Evaluating the Effects of Electroacupuncture and Rosiglitazone Combined Therapy on Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus With Features of Insulin Resistance
Keywords: electroacupuncture
rosiglitazone
plasma glucose
insulin resistance
free fatty acid
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2012-04-13
Enrollment: 49
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: plasma glucose
timeFrame: Time point(s) at which outcome measure is assessed in one year
Secondary outcomes:
measure: plasma free fatty acid (FFA)
timeFrame: Time point(s) at which outcome measure is assessed in one year.
measure: plasma insulin
timeFrame: Time point(s) at which outcome measure is assessed in one yease
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Department of Integrative Chinese-Western Clinic, China Medical University Hospital
Study officials:
affiliation: China Medical University, China
name: Shih-Liang Chang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.