Trial record 19 of 209 for:    Open Studies | acupuncture

Acupuncture for Obesity on Serum Metabolic Parameters

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Kyung Hee University Gangdong Hospital
Sponsor:
Information provided by (Responsible Party):
Mi-Yeon Song, Kyung Hee University Gangdong Hospital
ClinicalTrials.gov Identifier:
NCT02066090
First received: February 14, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Obesity
Device: Real acupuncture
Device: Sham acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Acupuncture on Serum Metabolic Parameters in Pre-menopausal Obese Women: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Kyung Hee University Gangdong Hospital:

Primary Outcome Measures:
  • change in serum metabolic profile [ Time Frame: before treatment at week1 (baseline) and after treatment at week6 (endpoint) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in body weight [ Time Frame: baseline, 1, 2, 3, 4, 5, and 6 weeks ] [ Designated as safety issue: No ]
    using bioelectrical impedance analysis (BIA)

  • change in body fat mass [ Time Frame: baseline, 1, 2, 3, 4, 5, and 6 weeks ] [ Designated as safety issue: No ]
    using bioelectrical impedance analysis (BIA)

  • change in muscle mass [ Time Frame: baseline, 1, 2, 3, 4, 5, and 6 weeks ] [ Designated as safety issue: No ]
    using bioelectrical impedance analysis (BIA)

  • change in waist circumference [ Time Frame: baseline, 1, 2, 3, 4, 5, and 6 weeks ] [ Designated as safety issue: No ]
  • change in hip circumference [ Time Frame: baseline, 1, 2, 3, 4, 5, and 6 weeks ] [ Designated as safety issue: No ]
  • change in Beck Depression Index (BDI) [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
  • change in Social Readjustment Rating Scale (SRRS) [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
  • change in Stress Response Inventory (SRI) [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
  • change in International Physical Activity Questionnaire (IPAQ) [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
  • change in Fatigue Severity Scale (FSS) [ Time Frame: baseline, 1, 2, 3, 4, 5, and 6 weeks ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • number of participants with adverse events [ Time Frame: up to the end of study ] [ Designated as safety issue: Yes ]
    • assessment of severity: mild, moderate, severe
    • assessment of relation: definitely related, probably related, possibly related, probably not related, definitely not related, unknown


Other Outcome Measures:
  • change in Measure Yourself Medical Outcome Profile (MYMOP) [ Time Frame: baseline, 1, 2, 3, 4, 5, and 6 weeks ] [ Designated as safety issue: No ]
    outcome measure for the evaluation of patients' satisfaction and economic efficacy in secondary sub-study

  • change in EuroQol-5 Dimension (EQ-5D) [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
    outcome measure for the evaluation of patients' satisfaction and economic efficacy in secondary sub-study


Estimated Enrollment: 120
Study Start Date: March 2014
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Real acupuncture
manual acupuncture + electroacupuncture, twice a week, for 6 weeks
Device: Real 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

Sham Comparator: Sham acupuncture
sham acupuncture + Mock TENS, twice a week, for 6 weeks
Device: Sham acupuncture

sham acupuncture (bilateral LI4, LI11, SP6, ST25, ST28, ST36) + Mock TENS (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)

mock TENS as control for electroacupuncture (0.25mm diameter x 90mm length, stainless steel, Dongbangacupuncture Inc., Korea)


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

Ages Eligible for Study:   19 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02066090

Contacts
Contact: Yo-Chan Yang 82-2-440-7577 ehanabi@hanmail.net
Contact: Koh-Woon Kim 82-2-440-7575 garson83@hanmail.net

Locations
Korea, Republic of
Kyung Hee University Korean Medicine Hospital at Gangdong Not yet recruiting
Seoul, Korea, Republic of, 134-727
Contact: Yo-Chan Yang    82-2-440-7577    ehanabi@hanmail.net   
Contact: Koh-Woon Kim    82-2-440-7575    garson83@hanmail.net   
Principal Investigator: Mi-Yeon Song, Ph.D.         
Sub-Investigator: Jae-Heung Cho, Ph.D.         
Sub-Investigator: Koh-Woon Kim, Ph.D.         
Sub-Investigator: Yo-Chan Yang         
Sponsors and Collaborators
Kyung Hee University Gangdong Hospital
Investigators
Principal Investigator: Mi-Yeon Song, Ph.D. Department of Rehabilitation Medicine of Korean Medicine, Kyung Hee University Gangdong Hospital
  More Information

No publications provided

Responsible Party: Mi-Yeon Song, Professor, K.M.D., Ph.D., Kyung Hee University Gangdong Hospital
ClinicalTrials.gov Identifier: NCT02066090     History of Changes
Other Study ID Numbers: KHNMCOH 2013-01-020
Study First Received: February 14, 2014
Last Updated: February 14, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Kyung Hee University Gangdong Hospital:
acupuncture
obesity
metabolomics

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014