Acupuncture for Obesity on Serum Metabolic Parameters

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Acupuncture on Serum Metabolic Parameters in Pre-menopausal Obese Women: A Randomized Controlled Trial

Conditions
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Obesity

Intervention / Treatment
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* Device: Real acupuncture
* Device: Sham acupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real acupuncture<br>manual acupuncture + electroacupuncture, twice a week, for 6 weeks | Device: Real acupuncture<br>* 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<br>|
| Sham Comparator: Sham acupuncture<br>sham acupuncture + placebo acupuncture without electrical stimulation, twice a week, for 6 weeks | Device: Sham acupuncture<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in serum metabolic profile |  | before treatment at week1 (baseline) and after treatment at week6 (endpoint) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in body weight | using bioelectrical impedance analysis (BIA) | baseline, 1, 2, 3, 4, 5, and 6 weeks | 
| change in body fat mass | using bioelectrical impedance analysis (BIA) | baseline, 1, 2, 3, 4, 5, and 6 weeks | 
| change in muscle mass | using bioelectrical impedance analysis (BIA) | 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 | 
| change in Beck Depression Index (BDI) |  | baseline and 6 weeks | 
| change in Social Readjustment Rating Scale (SRRS) |  | baseline and 6 weeks | 
| change in Stress Response Inventory (SRI) |  | baseline and 6 weeks | 
| change in International Physical Activity Questionnaire (IPAQ) |  | baseline and 6 weeks | 
| change in Fatigue Severity Scale (FSS) |  | baseline, 1, 2, 3, 4, 5, and 6 weeks | 
| heart rate variability (HRV) |  | 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) | 
| number of participants with adverse events | assessment of severity: mild, moderate, severe assessment of relation: definitely related, probably related, possibly related, probably not related, definitely not related, unknown | up to the end of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metabolomics, acupuncture, obesity