Acupuncture for Obesity on Serum Metabolic Parameters
Effects of Acupuncture on Serum Metabolic Parameters in Pre-menopausal Obese Women: A Randomized Controlled Trial
1 other identifier
interventional
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Mar 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2014
CompletedFirst Posted
Study publicly available on registry
February 19, 2014
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedNovember 17, 2017
November 1, 2017
1.9 years
February 14, 2014
November 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change in serum metabolic profile
before treatment at week1 (baseline) and after treatment at week6 (endpoint)
Secondary Outcomes (12)
change in body weight
baseline, 1, 2, 3, 4, 5, and 6 weeks
change in body fat mass
baseline, 1, 2, 3, 4, 5, and 6 weeks
change in muscle mass
baseline, 1, 2, 3, 4, 5, and 6 weeks
change in waist circumference
baseline, 1, 2, 3, 4, 5, and 6 weeks
change in hip circumference
baseline, 1, 2, 3, 4, 5, and 6 weeks
- +7 more secondary outcomes
Other Outcomes (2)
change in Measure Yourself Medical Outcome Profile (MYMOP)
baseline, 1, 2, 3, 4, 5, and 6 weeks
change in EuroQol-5 Dimension (EQ-5D)
baseline and 6 weeks
Study Arms (2)
Real acupuncture
EXPERIMENTALmanual acupuncture + electroacupuncture, twice a week, for 6 weeks
Sham acupuncture
SHAM COMPARATORsham acupuncture + placebo acupuncture without electrical stimulation, twice a week, for 6 weeks
Interventions
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 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)
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kyung Hee University Korean Medicine Hospital at Gangdong
Seoul, 134-727, South Korea
Related Publications (2)
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.
PMID: 32299241DERIVEDKim 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.
PMID: 26238111DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mi-Yeon Song, Ph.D.
Department of Rehabilitation Medicine of Korean Medicine, Kyung Hee University Gangdong Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, K.M.D., Ph.D.
Study Record Dates
First Submitted
February 14, 2014
First Posted
February 19, 2014
Study Start
March 1, 2014
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
November 17, 2017
Record last verified: 2017-11