Acupuncture for Obesity on Serum Metabolic Parameters
Effects of Acupuncture on Serum Metabolic Parameters in Pre-menopausal Obese Women: A Randomized Controlled Trial
調査の概要
詳細な説明
It is consisted with two sub research.
First, clinical research to assess the effect of acupuncture for obesity on serum metabolic parameters will be processed with randomized, patient-assessor blinding, and sham-acupuncture controlled study design. 120 subjects would be collected and divided into two groups(experimental and placebo, 60 subjects each). Experimental group will undergo with real acupuncture treatment(manual acupuncture + electroacupuncture) twice a week, for 6 weeks. The effect on serum metabolic parameters will be assessed at 0 and 6 weeks.
Second is qualitative research to make a basis through the evaluation of economic efficacy and patients' satisfaction with acupuncture treatment for obesity.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Seoul、大韓民国、134-727
- Kyung Hee University Korean Medicine Hospital at Gangdong
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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:
- volunteers through announcements and advertisements
- premenopausal adult women (19 years of age or more)
- clinical diagnosis of obesity (Body mass index: 25 kg/m2 or more)
Exclusion Criteria:
- previously or currently having endocrine disease such as hypothyroidism or Cushing's syndrome, heart disease, lung disease, diabetes, malignant tumor, cholelithiasis, severe kidney impairment, severe liver impairment, anorexia nervosa or hyperorexia
- experience of taking medicines which might affect body weight and the concentration of serum metabolic parameters such as anorectic, laxative, oral steroid, thyroid hormone, amphetamine, cyproheptadine, phenothiazine, or medicines affecting absorption, metabolism, and excretion in the past 3 months
- experience of taking beta-blocker or diuretic for the treatment of hypertension in the past 3 months
- surgical treatment for the treatment of obesity
- currently or might be pregnant or breast-feeding
- experience of taking other experimental medicines in the past month
- weight loss of 10% or more of previous body weight in the past 6 months
- who stopped smoking in the past 3 months or who have irregular smoking habit
- pacemaker
- currently receiving any treatment for obesity
- other inadequate subjects assessed by the study investigators
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：ダブル
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：Real acupuncture
manual acupuncture + electroacupuncture, twice a week, for 6 weeks
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manual acupuncture (bilateral LI4, LI11, SP6, ST25, ST28, ST36) + electroacupuncture (middle CV6, CV12), twice a week, for 6 weeks common approaches for the treatment of obesity used by doctors of Korean medicine in Korea today |
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偽コンパレータ：Sham acupuncture
sham acupuncture + placebo acupuncture without electrical stimulation, twice a week, for 6 weeks
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sham acupuncture (bilateral LI4, LI11, SP6, ST25, ST28, ST36) + placebo acupuncture without electrical stimulation (middle CV6, CV12), twice a week, for 6 weeks sham acupuncture (0.25mm diameter x 40mm length, stainless steel, Acuprime, UK) as control for manual acupuncture (0.25mm diameter x 40mm length, stainless steel, Dongbangacupuncture Inc., Korea) placebo acupuncture without electrical stimulation as control for electroacupuncture (0.25mm diameter x 90mm length, stainless steel, Dongbangacupuncture Inc., Korea) |
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 |
時間枠 |
|---|---|
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change in serum metabolic profile
時間枠：before treatment at week1 (baseline) and after treatment at week6 (endpoint)
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before treatment at week1 (baseline) and after treatment at week6 (endpoint)
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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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change in body weight
時間枠：baseline, 1, 2, 3, 4, 5, and 6 weeks
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using bioelectrical impedance analysis (BIA)
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baseline, 1, 2, 3, 4, 5, and 6 weeks
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change in body fat mass
時間枠：baseline, 1, 2, 3, 4, 5, and 6 weeks
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using bioelectrical impedance analysis (BIA)
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baseline, 1, 2, 3, 4, 5, and 6 weeks
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change in muscle mass
時間枠：baseline, 1, 2, 3, 4, 5, and 6 weeks
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using bioelectrical impedance analysis (BIA)
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baseline, 1, 2, 3, 4, 5, and 6 weeks
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change in waist circumference
時間枠：baseline, 1, 2, 3, 4, 5, and 6 weeks
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baseline, 1, 2, 3, 4, 5, and 6 weeks
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change in hip circumference
時間枠：baseline, 1, 2, 3, 4, 5, and 6 weeks
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baseline, 1, 2, 3, 4, 5, and 6 weeks
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change in Beck Depression Index (BDI)
時間枠：baseline and 6 weeks
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baseline and 6 weeks
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change in Social Readjustment Rating Scale (SRRS)
時間枠：baseline and 6 weeks
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baseline and 6 weeks
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change in Stress Response Inventory (SRI)
時間枠：baseline and 6 weeks
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baseline and 6 weeks
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change in International Physical Activity Questionnaire (IPAQ)
時間枠：baseline and 6 weeks
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baseline and 6 weeks
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change in Fatigue Severity Scale (FSS)
時間枠：baseline, 1, 2, 3, 4, 5, and 6 weeks
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baseline, 1, 2, 3, 4, 5, and 6 weeks
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heart rate variability (HRV)
時間枠：just before treatment at visit1(baseline), 10 minutes after treatment at visit1, just before treatment at visit12 (6 weeks), 10 minutes after treatment at visit12(end point)
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just before treatment at visit1(baseline), 10 minutes after treatment at visit1, just before treatment at visit12 (6 weeks), 10 minutes after treatment at visit12(end point)
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number of participants with adverse events
時間枠：up to the end of study
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up to the end of study
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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change in Measure Yourself Medical Outcome Profile (MYMOP)
時間枠：baseline, 1, 2, 3, 4, 5, and 6 weeks
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outcome measure for the evaluation of patients' satisfaction and economic efficacy in secondary sub-study
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baseline, 1, 2, 3, 4, 5, and 6 weeks
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change in EuroQol-5 Dimension (EQ-5D)
時間枠：baseline and 6 weeks
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outcome measure for the evaluation of patients' satisfaction and economic efficacy in secondary sub-study
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baseline and 6 weeks
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協力者と研究者
捜査官
- 主任研究者：Mi-Yeon Song, Ph.D.、Department of Rehabilitation Medicine of Korean Medicine, Kyung Hee University Gangdong Hospital
出版物と役立つリンク
一般刊行物
- Kim KW, Shin WC, Choi MS, Cho JH, Park HJ, Yoo HH, Song MY. Effects of acupuncture on anthropometric and serum metabolic parameters in premenopausal overweight and obese women: a randomized, patient- and assessor-blind, sham-controlled clinical trial. Acupunct Med. 2021 Feb;39(1):30-40. doi: 10.1177/0964528420912259. Epub 2020 Apr 17.
- Kim KW, Yoo HH, Cho JH, Yang YC, Kim JI, Kim SY, Park JY, Park HJ, Song MY. Effects of acupuncture on serum metabolic parameters in premenopausal obese women: study protocol for a randomized controlled trial. Trials. 2015 Aug 4;16:327. doi: 10.1186/s13063-015-0867-y.
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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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