Obesity
Conditions
Keywords
acupuncture, obesity, metabolomics
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.
Interventions
DEVICEReal acupuncture
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
DEVICESham acupuncture
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)
Sponsors
Kyung Hee University Hospital at Gangdong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in serum metabolic profile | before treatment at week1 (baseline) and after treatment at week6 (endpoint) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in body weight | baseline, 1, 2, 3, 4, 5, and 6 weeks | using bioelectrical impedance analysis (BIA) |
| change in body fat mass | baseline, 1, 2, 3, 4, 5, and 6 weeks | using bioelectrical impedance analysis (BIA) |
| 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 hip circumference | baseline, 1, 2, 3, 4, 5, and 6 weeks | — |
| change in Beck Depression Index (BDI) | 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) | — |
| 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 |
| 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 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| change in Measure Yourself Medical Outcome Profile (MYMOP) | baseline, 1, 2, 3, 4, 5, and 6 weeks | outcome measure for the evaluation of patients' satisfaction and economic efficacy in secondary sub-study |
| change in EuroQol-5 Dimension (EQ-5D) | baseline and 6 weeks | outcome measure for the evaluation of patients' satisfaction and economic efficacy in secondary sub-study |
Countries
South Korea
Outcome results
None listed