Evaluating the Effects of Electroacupuncture and Rosiglitazone Combined Therapy

NCT01577095 | Completed Phase 2 DMC

• 1 other identifier: DMR94-IRB-139
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus With Features of Insulin Resistance

Keywords

electroacupuncture; rosiglitazone; plasma glucose; insulin resistance; free fatty acid

Outcome Measures

Primary Outcomes (1)

• 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.

  Time point(s) at which outcome measure is assessed in one year

Secondary Outcomes (2)

• plasma free fatty acid (FFA)

  Time point(s) at which outcome measure is assessed in one year.

• plasma insulin

  Time point(s) at which outcome measure is assessed in one yease

Study Arms (2)

EA + Rosiglitazone

EXPERIMENTAL

Other: EA + Rosiglitazone

Rosiglitazone

PLACEBO COMPARATOR

Drug: TZD

Interventions

EA + Rosiglitazone OTHER

electroacupuncture and Rosiglitazone combined therapy on patient of type II DM

Also known as: Electroacupuncture and Rosiglitazone combined therapy

EA + Rosiglitazone

TZD DRUG

Rosiglitazone 8 mg single dose

Also known as: The effect of hypoglycemia and improving insulin sensitivity

Rosiglitazone

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

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

Taichung, Taiwan, 404, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 20633486 BACKGROUND

• 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.

  PMID: 23983807 DERIVED

MeSH Terms

Conditions

Insulin Resistance

Interventions

Rosiglitazone; Electroacupuncture

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Shih-Liang Chang, PhD

  China Medical University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2012
• First Posted: April 13, 2012
• Study Start: April 1, 2006
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: April 13, 2012

Record last verified: 2012-04

Locations

TW (1)