Acupuncture for Obesity on Serum Metabolic Parameters
14. november 2017 oppdatert av: Mi-Yeon Song, Kyung Hee University Hospital at Gangdong
Effects of Acupuncture on Serum Metabolic Parameters in Pre-menopausal Obese Women: A Randomized Controlled Trial
This research is planned to build a basis about the effect of acupuncture on serum metabolic parameters in pre-menopausal obese women with economic evaluation.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
120
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Seoul, Korea, Republikken, 134-727
- Kyung Hee University Korean Medicine Hospital at Gangdong
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
19 år til 55 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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 |
|
Sham-komparator: Sham acupuncture
sham acupuncture + placebo acupuncture without electrical stimulation, twice a week, for 6 weeks
|
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) |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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change in serum metabolic profile
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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change in body weight
Tidsramme: 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
Tidsramme: 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
Tidsramme: baseline, 1, 2, 3, 4, 5, and 6 weeks
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using bioelectrical impedance analysis (BIA)
|
baseline, 1, 2, 3, 4, 5, and 6 weeks
|
|
change in waist circumference
Tidsramme: 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
Tidsramme: 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)
Tidsramme: baseline and 6 weeks
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baseline and 6 weeks
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change in Social Readjustment Rating Scale (SRRS)
Tidsramme: baseline and 6 weeks
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baseline and 6 weeks
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change in Stress Response Inventory (SRI)
Tidsramme: baseline and 6 weeks
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baseline and 6 weeks
|
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change in International Physical Activity Questionnaire (IPAQ)
Tidsramme: baseline and 6 weeks
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baseline and 6 weeks
|
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change in Fatigue Severity Scale (FSS)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: up to the end of study
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up to the end of study
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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change in Measure Yourself Medical Outcome Profile (MYMOP)
Tidsramme: 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)
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Mi-Yeon Song, Ph.D., Department of Rehabilitation Medicine of Korean Medicine, Kyung Hee University Gangdong Hospital
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. mars 2014
Primær fullføring (Faktiske)
1. februar 2016
Studiet fullført (Faktiske)
1. februar 2016
Datoer for studieregistrering
Først innsendt
14. februar 2014
Først innsendt som oppfylte QC-kriteriene
14. februar 2014
Først lagt ut (Anslag)
19. februar 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. november 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. november 2017
Sist bekreftet
1. november 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- KHNMCOH 2013-01-020
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