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Completed

NCT Number: NCT02066090

Acupuncture for Obesity on Serum Metabolic Parameters

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kyung Hee University Korean Medicine Hospital at Gangdong

Seoul, 134-727, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Real Acupuncture

Device

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

Device

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)

Primary outcomes

  1. change in serum metabolic profile

    Time frame: before treatment at week1 (baseline) and after treatment at week6 (endpoint)

Secondary outcomes

  1. change in body weight

    Time frame: baseline, 1, 2, 3, 4, 5, and 6 weeks

    using bioelectrical impedance analysis (BIA)

  2. change in body fat mass

    Time frame: baseline, 1, 2, 3, 4, 5, and 6 weeks

    using bioelectrical impedance analysis (BIA)

  3. change in muscle mass

    Time frame: baseline, 1, 2, 3, 4, 5, and 6 weeks

    using bioelectrical impedance analysis (BIA)

  4. change in waist circumference

    Time frame: baseline, 1, 2, 3, 4, 5, and 6 weeks

  5. change in hip circumference

    Time frame: baseline, 1, 2, 3, 4, 5, and 6 weeks

  6. change in Beck Depression Index (BDI)

    Time frame: baseline and 6 weeks

  7. change in Social Readjustment Rating Scale (SRRS)

    Time frame: baseline and 6 weeks

  8. change in Stress Response Inventory (SRI)

    Time frame: baseline and 6 weeks

  9. change in International Physical Activity Questionnaire (IPAQ)

    Time frame: baseline and 6 weeks

  10. change in Fatigue Severity Scale (FSS)

    Time frame: baseline, 1, 2, 3, 4, 5, and 6 weeks

  11. heart rate variability (HRV)

    Time frame: 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)

  12. number of participants with adverse events

    Time frame: 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

Other outcomes

  1. change in Measure Yourself Medical Outcome Profile (MYMOP)

    Time frame: baseline, 1, 2, 3, 4, 5, and 6 weeks

    outcome measure for the evaluation of patients' satisfaction and economic efficacy in secondary sub-study

  2. change in EuroQol-5 Dimension (EQ-5D)

    Time frame: baseline and 6 weeks

    outcome measure for the evaluation of patients' satisfaction and economic efficacy in secondary sub-study

Sponsors and collaborators

Lead sponsor

Kyung Hee University Hospital at Gangdong

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 19, 2014
Registry last updated
Nov 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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