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Acupuncture for Obesity on Serum Metabolic Parameters

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Real acupuncture
Sham acupuncture
Sponsored by
Kyung Hee University Hospital at Gangdong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring acupuncture, obesity, metabolomics

Eligibility Criteria

19 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Kyung Hee University Korean Medicine Hospital at Gangdong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Real acupuncture

Sham acupuncture

Arm Description

manual acupuncture + electroacupuncture, twice a week, for 6 weeks

sham acupuncture + placebo acupuncture without electrical stimulation, twice a week, for 6 weeks

Outcomes

Primary Outcome Measures

change in serum metabolic profile

Secondary Outcome Measures

change in body weight
using bioelectrical impedance analysis (BIA)
change in body fat mass
using bioelectrical impedance analysis (BIA)
change in muscle mass
using bioelectrical impedance analysis (BIA)
change in waist circumference
change in hip circumference
change in Beck Depression Index (BDI)
change in Social Readjustment Rating Scale (SRRS)
change in Stress Response Inventory (SRI)
change in International Physical Activity Questionnaire (IPAQ)
change in Fatigue Severity Scale (FSS)
heart rate variability (HRV)
number of participants with adverse events
assessment of severity: mild, moderate, severe assessment of relation: definitely related, probably related, possibly related, probably not related, definitely not related, unknown

Full Information

First Posted
February 14, 2014
Last Updated
November 14, 2017
Sponsor
Kyung Hee University Hospital at Gangdong
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1. Study Identification

Unique Protocol Identification Number
NCT02066090
Brief Title
Acupuncture for Obesity on Serum Metabolic Parameters
Official Title
Effects of Acupuncture on Serum Metabolic Parameters in Pre-menopausal Obese Women: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyung Hee University Hospital at Gangdong

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
acupuncture, obesity, metabolomics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Real acupuncture
Arm Type
Experimental
Arm Description
manual acupuncture + electroacupuncture, twice a week, for 6 weeks
Arm Title
Sham acupuncture
Arm Type
Sham Comparator
Arm Description
sham acupuncture + placebo acupuncture without electrical stimulation, twice a week, for 6 weeks
Intervention Type
Device
Intervention Name(s)
Real acupuncture
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Sham acupuncture
Intervention Description
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 Outcome Measure Information:
Title
change in serum metabolic profile
Time Frame
before treatment at week1 (baseline) and after treatment at week6 (endpoint)
Secondary Outcome Measure Information:
Title
change in body weight
Description
using bioelectrical impedance analysis (BIA)
Time Frame
baseline, 1, 2, 3, 4, 5, and 6 weeks
Title
change in body fat mass
Description
using bioelectrical impedance analysis (BIA)
Time Frame
baseline, 1, 2, 3, 4, 5, and 6 weeks
Title
change in muscle mass
Description
using bioelectrical impedance analysis (BIA)
Time Frame
baseline, 1, 2, 3, 4, 5, and 6 weeks
Title
change in waist circumference
Time Frame
baseline, 1, 2, 3, 4, 5, and 6 weeks
Title
change in hip circumference
Time Frame
baseline, 1, 2, 3, 4, 5, and 6 weeks
Title
change in Beck Depression Index (BDI)
Time Frame
baseline and 6 weeks
Title
change in Social Readjustment Rating Scale (SRRS)
Time Frame
baseline and 6 weeks
Title
change in Stress Response Inventory (SRI)
Time Frame
baseline and 6 weeks
Title
change in International Physical Activity Questionnaire (IPAQ)
Time Frame
baseline and 6 weeks
Title
change in Fatigue Severity Scale (FSS)
Time Frame
baseline, 1, 2, 3, 4, 5, and 6 weeks
Title
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)
Title
number of participants with adverse events
Description
assessment of severity: mild, moderate, severe assessment of relation: definitely related, probably related, possibly related, probably not related, definitely not related, unknown
Time Frame
up to the end of study
Other Pre-specified Outcome Measures:
Title
change in Measure Yourself Medical Outcome Profile (MYMOP)
Description
outcome measure for the evaluation of patients' satisfaction and economic efficacy in secondary sub-study
Time Frame
baseline, 1, 2, 3, 4, 5, and 6 weeks
Title
change in EuroQol-5 Dimension (EQ-5D)
Description
outcome measure for the evaluation of patients' satisfaction and economic efficacy in secondary sub-study
Time Frame
baseline and 6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mi-Yeon Song, Ph.D.
Organizational Affiliation
Department of Rehabilitation Medicine of Korean Medicine, Kyung Hee University Gangdong Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyung Hee University Korean Medicine Hospital at Gangdong
City
Seoul
ZIP/Postal Code
134-727
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
32299241
Citation
Kim KW, Shin WC, Choi MS, Cho JH, Park HJ, Yoo HH, Song MY. Effects of acupuncture on anthropometric and serum metabolic parameters in premenopausal overweight and obese women: a randomized, patient- and assessor-blind, sham-controlled clinical trial. Acupunct Med. 2021 Feb;39(1):30-40. doi: 10.1177/0964528420912259. Epub 2020 Apr 17.
Results Reference
derived
PubMed Identifier
26238111
Citation
Kim KW, Yoo HH, Cho JH, Yang YC, Kim JI, Kim SY, Park JY, Park HJ, Song MY. Effects of acupuncture on serum metabolic parameters in premenopausal obese women: study protocol for a randomized controlled trial. Trials. 2015 Aug 4;16:327. doi: 10.1186/s13063-015-0867-y.
Results Reference
derived

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Acupuncture for Obesity on Serum Metabolic Parameters

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