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Evaluating the Effects of Electroacupuncture and Rosiglitazone Combined Therapy

Primary Purpose

Type 2 Diabetes Mellitus With Features of Insulin Resistance

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
EA + Rosiglitazone
TZD
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus With Features of Insulin Resistance focused on measuring electroacupuncture, rosiglitazone, plasma glucose, insulin resistance, free fatty acid

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

EA + Rosiglitazone

Rosiglitazone

Arm Description

Outcomes

Primary Outcome Measures

plasma glucose
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)
This secondary endpoint will compare the percent change of plasma FFA level between these two independent groups.
plasma insulin
This secondary endpoint will compare the plasma insulin level after treatment of each group and the change between these two independent groups.

Full Information

First Posted
March 27, 2012
Last Updated
April 12, 2012
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01577095
Brief Title
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

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus With Features of Insulin Resistance
Keywords
electroacupuncture, rosiglitazone, plasma glucose, insulin resistance, free fatty acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EA + Rosiglitazone
Arm Type
Experimental
Arm Title
Rosiglitazone
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
EA + Rosiglitazone
Other Intervention Name(s)
Electroacupuncture and Rosiglitazone combined therapy
Intervention Description
electroacupuncture and Rosiglitazone combined therapy on patient of type II DM
Intervention Type
Drug
Intervention Name(s)
TZD
Other Intervention Name(s)
The effect of hypoglycemia and improving insulin sensitivity
Intervention Description
Rosiglitazone 8 mg single dose
Primary Outcome Measure Information:
Title
plasma glucose
Description
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.
Time Frame
Time point(s) at which outcome measure is assessed in one year
Secondary Outcome Measure Information:
Title
plasma free fatty acid (FFA)
Description
This secondary endpoint will compare the percent change of plasma FFA level between these two independent groups.
Time Frame
Time point(s) at which outcome measure is assessed in one year.
Title
plasma insulin
Description
This secondary endpoint will compare the plasma insulin level after treatment of each group and the change between these two independent groups.
Time Frame
Time point(s) at which outcome measure is assessed in one yease

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shih-Liang Chang, PhD
Organizational Affiliation
China Medical University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Integrative Chinese-Western Clinic, China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
20633486
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.
Results Reference
background
PubMed Identifier
23983807
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.
Results Reference
derived

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Evaluating the Effects of Electroacupuncture and Rosiglitazone Combined Therapy

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