Evaluating the Effects of Electroacupuncture and Rosiglitazone Combined Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01577095
First received: March 27, 2012
Last updated: April 12, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus With Features of Insulin Resistance
Other: EA + Rosiglitazone
Drug: TZD
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Evaluating the Effects of Electroacupuncture and Rosiglitazone Combined Therapy on Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:
  • plasma glucose [ Time Frame: Time point(s) at which outcome measure is assessed in one year ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • plasma free fatty acid (FFA) [ Time Frame: Time point(s) at which outcome measure is assessed in one year. ] [ Designated as safety issue: No ]
    This secondary endpoint will compare the percent change of plasma FFA level between these two independent groups.

  • plasma insulin [ Time Frame: Time point(s) at which outcome measure is assessed in one yease ] [ Designated as safety issue: No ]
    This secondary endpoint will compare the plasma insulin level after treatment of each group and the change between these two independent groups.


Enrollment: 49
Study Start Date: April 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EA + Rosiglitazone Other: EA + Rosiglitazone
electroacupuncture and Rosiglitazone combined therapy on patient of type II DM
Other Name: Electroacupuncture and Rosiglitazone combined therapy
Placebo Comparator: Rosiglitazone Drug: TZD
Rosiglitazone 8 mg single dose
Other Name: The effect of hypoglycemia and improving insulin sensitivity

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01577095

Locations
Taiwan
Department of Integrative Chinese-Western Clinic, China Medical University Hospital
Taichung, Taiwan, 404
Sponsors and Collaborators
China Medical University Hospital
Investigators
Principal Investigator: Shih-Liang Chang, PhD China Medical University, China
  More Information

Additional Information:
Publications:
Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01577095     History of Changes
Other Study ID Numbers: DMR94-IRB-139
Study First Received: March 27, 2012
Last Updated: April 12, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by China Medical University Hospital:
electroacupuncture
rosiglitazone
plasma glucose
insulin resistance
free fatty acid

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014