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Electro-acupuncture for Central Obesity

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ClinicalTrials.gov Identifier: NCT03815253
Recruitment Status : Recruiting
First Posted : January 24, 2019
Last Update Posted : February 5, 2019
Sponsor:
Collaborator:
Princess Margaret Hospital, Hong Kong
Information provided by (Responsible Party):
Zhong Lidan, Hong Kong Baptist University

Brief Summary:
In this study, a 8-week, single blinded, randomized controlled clinical trial will be conducted to examine the efficacy and safety of body acupuncture in the treatment of central obesity in Hong Kong.

Condition or disease Intervention/treatment Phase
Central Obesity Other: acupuncture Not Applicable

Detailed Description:
This is a pilot single-blind, randomized, sham-controlled trial. 168 central obesity patients will be randomly assigned to acupuncture group or control group. The duration of the treatment will be 8 weeks with 2 session per week and the follow-up period will be 2 weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: single-blinded, randomized, sham-controlled clinical trial
Masking: Single (Participant)
Masking Description: Subjects of both groups will be randomly assigned to receive either electro-acupuncture or control (sham) treatment. For randomization, simple, complete non-sequential random numbers will be generated in advance by a computer program in a block of four, and kept by the principal investigator. After a patient's eligibility is confirmed, a randomization number which corresponds to the group allocation will be provided to the acupuncturist by the PI. This arrangement will ensure that the clinical assessor and participants are blinded to the allocation.
Primary Purpose: Treatment
Official Title: Electro-acupuncture for Central Obesity: a Single Blinded Randomized Sham-controlled Clinical Trial
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: Acupuncture group

Body electro-acupuncture will be conducted for 2 sessions per week over 8 consecutive weeks.

Body electro-acupuncture will choose eight acupoints as Tianshu(ST-25), Daheng(SP-15), Daimai(GB-26), Qihai(CV-6), Zhongwan(CV-12), Zusanli (ST-36), Fenlong(ST-40), Sanyinjiao(SP-6).Disposable acupuncture needles (verum acupuncture needles asia-med Special No. 16 with 0.30 x 0.30mm matching the Streitberger sham-needles) will be inserted at a depth of 10-25 mm into the points.

We will also deliver electrical stimulation with dense-disperse waves with 50Hz at 10 volts through electrical acupuncture stimulation instrument (ES-160 6-Channel Programmable Electro-acupuncture) to the abdominal points. The bodily needles will be retained for 30 minutes.

Other: acupuncture

Body electro-acupuncture will choose eight acupoints as Tianshu(ST-25), Daheng(SP-15), Daimai(GB-26), Qihai(CV-6), Zhongwan(CV-12), Zusanli (ST-36), Fenlong(ST-40), Sanyinjiao(SP-6).Disposable acupuncture needles (verum acupuncture needles asia-med Special No. 16 with 0.30 x 0.30mm matching the Streitberger sham-needles) will be inserted at a depth of 10-25 mm into the points.

We will also deliver electrical stimulation with dense-disperse waves with 50Hz at 10 volts through electrical acupuncture stimulation instrument (ES-160 6-Channel Programmable Electro-acupuncture) to the abdominal points. The bodily needles will be retained for 30 minutes.


Placebo Comparator: sham-acupuncture group
As to the participants allocated to control group, Streitberger's non-invasive acupuncture needles (Gauge 8 x 1.2" / 0.30 x 30 mm) will be applied to act as sham control at the same acupoints with same stimulation modality. However, the needles will be only adhered to the skin instead of insertion. The validity and credibility of this model has been well demonstrated.
Other: acupuncture

Body electro-acupuncture will choose eight acupoints as Tianshu(ST-25), Daheng(SP-15), Daimai(GB-26), Qihai(CV-6), Zhongwan(CV-12), Zusanli (ST-36), Fenlong(ST-40), Sanyinjiao(SP-6).Disposable acupuncture needles (verum acupuncture needles asia-med Special No. 16 with 0.30 x 0.30mm matching the Streitberger sham-needles) will be inserted at a depth of 10-25 mm into the points.

We will also deliver electrical stimulation with dense-disperse waves with 50Hz at 10 volts through electrical acupuncture stimulation instrument (ES-160 6-Channel Programmable Electro-acupuncture) to the abdominal points. The bodily needles will be retained for 30 minutes.





Primary Outcome Measures :
  1. Changes in waist circumference [ Time Frame: 0,1,2,3,4,5,6,7,8, 11, 15,18, 21, 24 weeks ]
    Waist circumference will be measured around the abdomen at the level of the umbilicus (belly button).


Secondary Outcome Measures :
  1. Changes in hip circumference [ Time Frame: 0,1,2,3,4,5,6,7,8,9,11,15,18, 21, 24 weeks ]
    hip circumference measured at the level of maximum posterior extension of the buttocks

  2. Adverse events after treatment and follow up [ Time Frame: 0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks ]
    Adverse events of acupuncture treatment will be assessed using the Treatment Emergent Symptom Scale (TESS) and would be evaluated during the whole procedure, as well as laboratory tests (whole blood counts, renal and liver functions) if needed. All clinical adverse events will be recorded in terms of intensity (mild, moderate, or severe), duration, outcome and relationship to the study.

  3. Changes in waist-to-hip circumference ratio [ Time Frame: 0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks ]
    waist-to-hip ratio is the dimensionless ratio of the circumference of the waist to that of the hips. This is calculated as waist measurement divided by hip measurement ( W ÷ H ).

  4. Changes in Body Mass Index [ Time Frame: 0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks ]
    Body Mass Index is a simple calculation using a person's height and weight. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared.

  5. Changes in body fat percentage [ Time Frame: 0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks ]
    The body fat percentage (BFP) of a human or other living being is the total mass of fat divided by total body mass, multiplied by 100. Body fat percentage will be measured by Omron Karada Scan HBF-701.

  6. Changes in total cholesterol (TC), triglyceride (TG) and fasting blood glucose (FBG) [ Time Frame: 0, 8 weeks ]
    Total cholesterol (TC), triglyceride (TG) and fasting blood glucose (FBG) will be measured before and after the 8-week treatment.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients who meet all of the following criteria are defined as eligible participants: men and women aged between 18 and 65 years old; BMI ≥ 25 kg/m2; central obesity, defined as WC of ≥ 90 cm in men and ≥ 80 cm in non-pregnant women according to ICD-10 [24]; not receiving any other weight control measures or any medical and/or drug history in last 3months.

Exclusion Criteria:

Patients who meet any of the following criteria should be excluded from the study: endocrine diseases, including thyroid disorder, pituitary disorder, sex gland disorder, etc.; heart diseases, including arrhythmia, heart failure, myocardial infarction, patients with pacemaker; allergy and immunology diseases; bleeding tendency; pregnant or lactating women; impaired hepatic or renal function; stroke or unable to exercise.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03815253


Contacts
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Contact: Linda Zhong, MD., Ph.D 852-34116523 ldzhong0305@gmail.com

Locations
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Hong Kong
Linda Zhong Recruiting
Kowloon Tong, Kowloon, Hong Kong
Contact: Linda Zhong, MD,PhD    34116523    ldzhong0305@gmail.com   
Contact: Tszfung Lam    34116501    lamtszfung@hkbu.edu.hk   
Sponsors and Collaborators
Hong Kong Baptist University
Princess Margaret Hospital, Hong Kong
Investigators
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Study Director: Zhaoxiang Bian, MD., Ph.D Hong Kong Chinese Medicine Clinical Study Centre

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Responsible Party: Zhong Lidan, Research Assistant Professor, Hong Kong Baptist University
ClinicalTrials.gov Identifier: NCT03815253     History of Changes
Other Study ID Numbers: HKBU-HMRF
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Obesity, Abdominal
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms