Acupuncture for Obesity on Serum Metabolic Parameters

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Device: Real acupuncture; Device: Sham acupuncture

• Registration Number: NCT02066090
• Lead Sponsor: Kyung Hee University Hospital at Gangdong

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.

Study Timeline

• Study First Submitted: 2014-02-14
• Study First Submitted QC: 2014-02-14
• Study First Posted: 2014-02-19
• Study Start: 2014-03
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-14
• Last Update Posted: 2017-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Real acupuncture	Real acupuncture	manual acupuncture + electroacupuncture, twice a week, for 6 weeks
Sham acupuncture	Sham acupuncture	sham acupuncture + placebo acupuncture without electrical stimulation, twice a week, for 6 weeks

Primary Outcome Measures

Name	Time	Method
change in serum metabolic profile	before treatment at week1 (baseline) and after treatment at week6 (endpoint)

Secondary Outcome Measures

Name	Time	Method
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 International Physical Activity Questionnaire (IPAQ)	baseline and 6 weeks
change in muscle mass	baseline, 1, 2, 3, 4, 5, and 6 weeks	using bioelectrical impedance analysis (BIA)
change in waist circumference	baseline, 1, 2, 3, 4, 5, and 6 weeks
change in Social Readjustment Rating Scale (SRRS)	baseline and 6 weeks
change in body weight	baseline, 1, 2, 3, 4, 5, and 6 weeks	using bioelectrical impedance analysis (BIA)
change in Stress Response Inventory (SRI)	baseline 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)
change in body fat mass	baseline, 1, 2, 3, 4, 5, and 6 weeks	using bioelectrical impedance analysis (BIA)
change in Fatigue Severity Scale (FSS)	baseline, 1, 2, 3, 4, 5, and 6 weeks
number of participants with adverse events	up to the end of study	* assessment of severity: mild, moderate, severe; * assessment of relation: definitely related, probably related, possibly related, probably not related, definitely not related, unknown

Trial Locations

Locations (1)

Kyung Hee University Korean Medicine Hospital at Gangdong; 🇰🇷 Seoul, Korea, Republic of