Acupuncture for Obesity on Serum Metabolic Parameters
Effects of Acupuncture on Serum Metabolic Parameters in Pre-menopausal Obese Women: A Randomized Controlled Trial
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Seoul, 대한민국, 134-727
- Kyung Hee University Korean Medicine Hospital at Gangdong
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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가짜 비교기: 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) |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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change in serum metabolic profile
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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change in body weight
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: baseline and 6 weeks
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baseline and 6 weeks
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change in Social Readjustment Rating Scale (SRRS)
기간: baseline and 6 weeks
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baseline and 6 weeks
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change in Stress Response Inventory (SRI)
기간: baseline and 6 weeks
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baseline and 6 weeks
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change in International Physical Activity Questionnaire (IPAQ)
기간: baseline and 6 weeks
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baseline and 6 weeks
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change in Fatigue Severity Scale (FSS)
기간: 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)
기간: 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
기간: up to the end of study
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up to the end of study
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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change in Measure Yourself Medical Outcome Profile (MYMOP)
기간: 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)
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Mi-Yeon Song, Ph.D., Department of Rehabilitation Medicine of Korean Medicine, Kyung Hee University Gangdong Hospital
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
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기본 완료 (실제)
연구 완료 (실제)
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최초 제출
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연구 기록 업데이트
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추가 정보
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