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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases
Rosiglitazone
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014