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NCT Number: NCT01577095

Evaluating the Effects of Electroacupuncture and Rosiglitazone Combined Therapy

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.

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Key information

Conditions

Type 2 Diabetes Mellitus with Features of Insulin Resistance Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Integrative Chinese-Western Clinic, China Medical University Hospital

Taichung, Taiwan, 404

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EA + Rosiglitazone

Other

electroacupuncture and Rosiglitazone combined therapy on patient of type II DM

Other names: Electroacupuncture and Rosiglitazone combined therapy

TZD

Drug

Rosiglitazone 8 mg single dose

Other names: The effect of hypoglycemia and improving insulin sensitivity

Primary outcomes

  1. plasma glucose

    Time frame: 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 outcomes

  1. plasma free fatty acid (FFA)

    Time frame: 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.

  2. plasma insulin

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Official study title

A Randomized Controlled Trial Evaluating the Effects of Electroacupuncture and Rosiglitazone Combined Therapy on Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Apr 13, 2012
Registry last updated
Apr 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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