Evaluating the Effects of Electroacupuncture and Rosiglitazone Combined Therapy
A Randomized Controlled Trial Evaluating the Effects of Electroacupuncture and Rosiglitazone Combined Therapy on Patients With Type 2 Diabetes Mellitus
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.
調査の概要
詳細な説明
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Taichung、台湾、404
- Department of Integrative Chinese-Western Clinic, China Medical University Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：EA + Rosiglitazone
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electroacupuncture and Rosiglitazone combined therapy on patient of type II DM
他の名前：
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プラセボコンパレーター：Rosiglitazone
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Rosiglitazone 8 mg single dose
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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plasma glucose
時間枠：Time point(s) at which outcome measure is assessed in one year
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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.
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Time point(s) at which outcome measure is assessed in one year
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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plasma free fatty acid (FFA)
時間枠：Time point(s) at which outcome measure is assessed in one year.
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This secondary endpoint will compare the percent change of plasma FFA level between these two independent groups.
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Time point(s) at which outcome measure is assessed in one year.
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plasma insulin
時間枠：Time point(s) at which outcome measure is assessed in one yease
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This secondary endpoint will compare the plasma insulin level after treatment of each group and the change between these two independent groups.
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Time point(s) at which outcome measure is assessed in one yease
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協力者と研究者
捜査官
- 主任研究者：Shih-Liang Chang, PhD、China Medical University, China
出版物と役立つリンク
一般刊行物
- 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.
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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