Acupuncture for Obesity on Serum Metabolic Parameters

November 14, 2017 updated by: Mi-Yeon Song, Kyung Hee University Hospital at Gangdong

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 134-727
        • Kyung Hee University Korean Medicine Hospital at Gangdong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 + placebo acupuncture without electrical stimulation, twice a week, for 6 weeks
Device: Sham 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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in body weight
Time Frame: baseline, 1, 2, 3, 4, 5, and 6 weeks
using bioelectrical impedance analysis (BIA)
baseline, 1, 2, 3, 4, 5, and 6 weeks
change in body fat mass
Time Frame: baseline, 1, 2, 3, 4, 5, and 6 weeks
using bioelectrical impedance analysis (BIA)
baseline, 1, 2, 3, 4, 5, and 6 weeks
change in muscle mass
Time Frame: baseline, 1, 2, 3, 4, 5, and 6 weeks
using bioelectrical impedance analysis (BIA)
baseline, 1, 2, 3, 4, 5, and 6 weeks
change in waist circumference
Time Frame: baseline, 1, 2, 3, 4, 5, and 6 weeks
baseline, 1, 2, 3, 4, 5, and 6 weeks
change in hip circumference
Time Frame: baseline, 1, 2, 3, 4, 5, and 6 weeks
baseline, 1, 2, 3, 4, 5, and 6 weeks
change in Beck Depression Index (BDI)
Time Frame: baseline and 6 weeks
baseline and 6 weeks
change in Social Readjustment Rating Scale (SRRS)
Time Frame: baseline and 6 weeks
baseline and 6 weeks
change in Stress Response Inventory (SRI)
Time Frame: baseline and 6 weeks
baseline and 6 weeks
change in International Physical Activity Questionnaire (IPAQ)
Time Frame: baseline and 6 weeks
baseline and 6 weeks
change in Fatigue Severity Scale (FSS)
Time Frame: baseline, 1, 2, 3, 4, 5, and 6 weeks
baseline, 1, 2, 3, 4, 5, and 6 weeks
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)
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
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
up to the end of study

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, 1, 2, 3, 4, 5, and 6 weeks
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
baseline and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyung Hee University Hospital at Gangdong

Investigators

  • Principal Investigator: Mi-Yeon Song, Ph.D., Department of Rehabilitation Medicine of Korean Medicine, Kyung Hee University Gangdong Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

February 14, 2014

First Submitted That Met QC Criteria

February 14, 2014

First Posted (Estimate)

February 19, 2014

Study Record Updates

Last Update Posted (Actual)

November 17, 2017

Last Update Submitted That Met QC Criteria

November 14, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KHNMCOH 2013-01-020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Real acupuncture

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe