Clinical trial NCT02066090: Acupuncture for Obesity on Serum Metabolic Parameters
Official title: Effects of Acupuncture on Serum Metabolic Parameters in Pre-menopausal Obese Women: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: acupuncture
obesity
metabolomics
Lead sponsor: Kyung Hee University Hospital at Gangdong
Sponsor class: OTHER
First posted: 2014-02-19
Enrollment: 120
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: change in serum metabolic profile
timeFrame: before treatment at week1 (baseline) and after treatment at week6 (endpoint)
Secondary outcomes:
measure: change in body weight
timeFrame: baseline, 1, 2, 3, 4, 5, and 6 weeks
measure: change in body fat mass
timeFrame: baseline, 1, 2, 3, 4, 5, and 6 weeks
measure: change in muscle mass
timeFrame: baseline, 1, 2, 3, 4, 5, and 6 weeks
measure: change in waist circumference
timeFrame: baseline, 1, 2, 3, 4, 5, and 6 weeks
measure: change in hip circumference
timeFrame: baseline, 1, 2, 3, 4, 5, and 6 weeks
measure: change in Beck Depression Index (BDI)
timeFrame: baseline and 6 weeks
measure: change in Social Readjustment Rating Scale (SRRS)
timeFrame: baseline and 6 weeks
measure: change in Stress Response Inventory (SRI)
timeFrame: baseline and 6 weeks
measure: change in International Physical Activity Questionnaire (IPAQ)
timeFrame: baseline and 6 weeks
measure: change in Fatigue Severity Scale (FSS)
timeFrame: baseline, 1, 2, 3, 4, 5, and 6 weeks
measure: heart rate variability (HRV)
timeFrame: 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)
measure: number of participants with adverse events
timeFrame: up to the end of study
Other outcomes:
measure: change in Measure Yourself Medical Outcome Profile (MYMOP)
timeFrame: baseline, 1, 2, 3, 4, 5, and 6 weeks
measure: change in EuroQol-5 Dimension (EQ-5D)
timeFrame: baseline and 6 weeks
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Korean Medicine Hospital at Gangdong
Study officials:
affiliation: Department of Rehabilitation Medicine of Korean Medicine, Kyung Hee University Gangdong Hospital
name: Mi-Yeon Song, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.