Efficacy of Electro-acupuncture for Abdominal Obesity: Study for a Randomized Controlled Trial

Obesity, Abdominal Clinical Trial

Official title:

The Efficacy and Safety of Electro-acupuncture for Abdominal Obesity: Original Study for a Multicenter, Randomized, Sham-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04957134
• Other study ID #: ZY2021Z004
• Status: Completed
• Phase: N/A
• Start date: July 22, 2021
• Est. completion date: March 15, 2023

Study information

• Verified date: June 2023
• Source: Hubei Hospital of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Electro-acupuncture provides stimulation to acupoints, and has been widely used to treat abdominal obesity in China despite of lack of high-level evidence for treatment efficacy. The study will investigate whether the electroacupuncture can alleviate clinical symptoms and the mechanism of action in patients with abdominal obesity.

Description:

The study will be a randomized controlled trial from May 2021 to December 2022, including 68 participants with abdominal obesity. The participants will be randomly divided into 2 groups in a 1:1 allocation ratio.The intervention group will receive electroacupuncture; the control group will receive sham acupuncture. Each treatment will last 12 weeks, including 8 weeks of intervention period and 24 weeks of follow-up. The primary outcome is the waist circumference (WC), the secondary outcomes include weight, body mass index (BMI), hipline, waist-hip-ratio (WHR), Insulin resistance index (IRI), blood fat, metabolomics will be used analysis the mechanism. The adverse events will be recorded during the intervention and follow-up period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 15, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Patients recruited for this study should meet the following inclusion criteria:

1.Satisfying the criteria for the diagnosis of abdominal obesity; 2.18 years old=age=55 years old; 3.Being able to fully understand and voluntarily sign informed consent.

Exclusion Criteria:

• Patients with any of the following criteria will be excluded from the study:

1. Presence of endocrine disorders such as: polycystic ovary syndrome; Cushing's syndrome; uncorrected thyroid disease.

2. Presence of diabetes mellitus, or hypertension, or abnormal liver and kidney functions, or mental diseases.

3. Pregnant or lactating state, women who plan to become pregnant within 12 weeks.

4. History of bulimia, anorexia, or any other eating disorders.

5. Use of medications in the past 3 months, such as diet drugs, corticosteroids, antidepressants, which may affect weight or appetite.

6. History of surgical weight loss, postoperative adhesions.

7. History of participating in a clinical study of weight loss or any other therapies to lose weight in the past 3 months.

8. Unable to cooperate with the research caused by other diseases or reasons.

9. Received acupuncture within 6 months before enrollment

Related Conditions & MeSH terms

• Obesity
• Obesity, Abdominal

Intervention

Device:
• Electro-acupuncture
The acupoints of electro-acupuncture will be selected as Zusanli ,Sanyinjiao ,Zhongwan , Tianshu , Shuifen , Daheng ,Daimai , Shuidao ,Huaroumen and Fujie . We will deliver electrical stimulation with dense-disperse waves at 50 Hz and 10 V through the electrical acupuncture stimulation instrument to the abdominal points. The bodily needles will be retained for 30 minutes . Electro-acupuncture treatment will be applied 3 times a week, once every other day, for 8 consecutive weeks.
• Sham electro-acupuncture
The acupoints of sham electro-acupuncture will be selected as nonacupoints . The internal output power cord of the electrical acupuncture stimulation instrument will be interrupted. The bodily needles will be retained for 30 minutes . Sham acupuncture treatment will be applied 3 times a week, once every other day, for 8 consecutive weeks.

Locations

Country	Name	City	State
China	Hubei Provincial Hospital of Traditional Chinese Medicine	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Hubei Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

References & Publications (22)

Biemann R, Roomp K, Noor F, Krishnan S, Li Z, Shahzad K, Borucki K, Luley C, Schneider JG, Isermann B. Gene expression profile of CD14+ blood monocytes following lifestyle-induced weight loss in individuals with metabolic syndrome. Sci Rep. 2020 Oct 20;10(1):17855. doi: 10.1038/s41598-020-74973-2. — View Citation

Carbone A, Al Salhi Y, Tasca A, Palleschi G, Fuschi A, De Nunzio C, Bozzini G, Mazzaferro S, Pastore AL. Obesity and kidney stone disease: a systematic review. Minerva Urol Nefrol. 2018 Aug;70(4):393-400. doi: 10.23736/S0393-2249.18.03113-2. Epub 2018 May 31. — View Citation

Chan EW, He Y, Chui CS, Wong AY, Lau WC, Wong IC. Efficacy and safety of lorcaserin in obese adults: a meta-analysis of 1-year randomized controlled trials (RCTs) and narrative review on short-term RCTs. Obes Rev. 2013 May;14(5):383-92. doi: 10.1111/obr.12015. Epub 2013 Jan 21. — View Citation

Chen X, Huang W, Hu F, Jin YT, Hong ZH, Zhou ZY. [Regularity of Acupoint Selection for Simple Obesity Treated by Acupoint Catgut Embedding Based on Complex Network Technology]. Zhen Ci Yan Jiu. 2018 Sep 25;43(9):585-90. doi: 10.13702/j.1000-0607.170448. Chinese. — View Citation

Chen X, Huang W, Wei D, Ding DG, Jiao Y, Pan HL, Jin YT, Zheng YW, Zhang YJ, Zhang YR, Liu YR, Zhou ZY. Clinical effect of catgut implantation at acupoints for the treatment of simple obesity: A multicentre randomized controlled trial. Medicine (Baltimore). 2020 Nov 25;99(48):e23390. doi: 10.1097/MD.0000000000023390. — View Citation

Gao Y, Wang Y, Zhou J, Hu Z, Shi Y. Effectiveness of Electroacupuncture for Simple Obesity: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Evid Based Complement Alternat Med. 2020 Jun 28;2020:2367610. doi: 10.1155/2020/2367610. eCollection 2020. — View Citation

Garvey WT, Mechanick JI, Brett EM, Garber AJ, Hurley DL, Jastreboff AM, Nadolsky K, Pessah-Pollack R, Plodkowski R; Reviewers of the AACE/ACE Obesity Clinical Practice Guidelines. AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY COMPREHENSIVE CLINICAL PRACTICE GUIDELINES FOR MEDICAL CARE OF PATIENTS WITH OBESITY. Endocr Pract. 2016 Jul;22 Suppl 3:1-203. doi: 10.4158/EP161365.GL. Epub 2016 May 24. — View Citation

Huang W, Chen X, Zhang Y, Wang L, Wang J, Zhang Y, Wei D, Zhou Z. Acupoint catgut embedding for obesity: A protocol of systematic review. Medicine (Baltimore). 2020 Dec 18;99(51):e23728. doi: 10.1097/MD.0000000000023728. — View Citation

Lee JJ, Sundar KM. Evaluation and Management of Adults with Obstructive Sleep Apnea Syndrome. Lung. 2021 Apr;199(2):87-101. doi: 10.1007/s00408-021-00426-w. Epub 2021 Mar 13. — View Citation

Liang CM, Hu H, Li YY. [Acupuncture treatment of abdominal obesity patients by "belt vessel (Daimai) regulating method"]. Zhen Ci Yan Jiu. 2012 Dec;37(6):493-6. Chinese. — View Citation

Liang CM, Hu H, Wang CX, Sun SG, Yang WJ, Pan L. [Randomized Controlled Clinical Trials for Acupuncture Treatment of Abdominal Obesity]. Zhen Ci Yan Jiu. 2016 Apr;41(2):159-62, 174. Chinese. — View Citation

Liu Z, Liu Y, Xu H, He L, Chen Y, Fu L, Li N, Lu Y, Su T, Sun J, Wang J, Yue Z, Zhang W, Zhao J, Zhou Z, Wu J, Zhou K, Ai Y, Zhou J, Pang R, Wang Y, Qin Z, Yan S, Li H, Luo L, Liu B. Effect of Electroacupuncture on Urinary Leakage Among Women With Stress Urinary Incontinence: A Randomized Clinical Trial. JAMA. 2017 Jun 27;317(24):2493-2501. doi: 10.1001/jama.2017.7220. — View Citation

Liu Z, Yan S, Wu J, He L, Li N, Dong G, Fang J, Fu W, Fu L, Sun J, Wang L, Wang S, Yang J, Zhang H, Zhang J, Zhao J, Zhou W, Zhou Z, Ai Y, Zhou K, Liu J, Xu H, Cai Y, Liu B. Acupuncture for Chronic Severe Functional Constipation: A Randomized Trial. Ann Intern Med. 2016 Dec 6;165(11):761-769. doi: 10.7326/M15-3118. Epub 2016 Sep 13. — View Citation

Matsueda K, Hongo M, Tack J, Saito Y, Kato H. A placebo-controlled trial of acotiamide for meal-related symptoms of functional dyspepsia. Gut. 2012 Jun;61(6):821-8. doi: 10.1136/gutjnl-2011-301454. Epub 2011 Dec 9. — View Citation

Scheen AJ, Van Gaal LF. Combating the dual burden: therapeutic targeting of common pathways in obesity and type 2 diabetes. Lancet Diabetes Endocrinol. 2014 Nov;2(11):911-22. doi: 10.1016/S2213-8587(14)70004-X. Epub 2014 Feb 19. — View Citation

Tronieri JS, Wadden TA, Walsh OA, Berkowitz RI, Alamuddin N, Gruber K, Leonard S, Chao AM. Effects of liraglutide plus phentermine in adults with obesity following 1 year of treatment by liraglutide alone: A randomized placebo-controlled pilot trial. Metabolism. 2019 Jul;96:83-91. doi: 10.1016/j.metabol.2019.03.005. Epub 2019 Mar 20. — View Citation

Viner RM, Hsia Y, Tomsic T, Wong IC. Efficacy and safety of anti-obesity drugs in children and adolescents: systematic review and meta-analysis. Obes Rev. 2010 Aug;11(8):593-602. doi: 10.1111/j.1467-789X.2009.00651.x. Epub 2009 Nov 17. — View Citation

Yu Z, Xia Y, Ju C, Shao Q, Mao Z, Gu Y, Xu B. Electroacupuncture regulates glucose-inhibited neurons in treatment of simple obesity. Neural Regen Res. 2013 Mar 25;8(9):809-16. doi: 10.3969/j.issn.1673-5374.2013.09.005. — View Citation

Zhang CY, Yang L. [Effect of Acupuncture Therapy on Visceral Fat Thickness in Simple Central Obesity Patients]. Zhen Ci Yan Jiu. 2015 Dec;40(6):484-8. Chinese. — View Citation

Zhang N, Du SM, Ma GS. Current lifestyle factors that increase risk of T2DM in China. Eur J Clin Nutr. 2017 Jul;71(7):832-838. doi: 10.1038/ejcn.2017.41. Epub 2017 Apr 19. — View Citation

Zhang YJ, Li J, Huang W, Mo GY, Wang LH, Zhuo Y, Zhou ZY. [Effect of electroacupuncture combined with treadmill exercise on body weight and expression of PGC-1alpha, Irisin and AMPK in skeletal muscle of diet-induced obesity rats]. Zhen Ci Yan Jiu. 2019 Jul 25;44(7):476-80. doi: 10.13702/j.1000-0607.180460. Chinese. — View Citation

Zhong LL, Kun W, Lam TF, Zhang SP, Yang JJ, Ziea TC, Ng B, Bian ZX. The combination effects of body acupuncture and auricular acupressure compared to sham acupuncture for body weight control: study protocol for a randomized controlled trial. Trials. 2016 Jul 25;17(1):346. doi: 10.1186/s13063-016-1458-2. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline waistline at 8 weeks.	Waistline will be measured around the abdomen at the level of the umbilicus (belly button).	week 0,week 4,week 8,week 20,week 32
Secondary	Change from baseline body weight at 8 weeks.	Body weight will be measured by a body composition analyzer (OMRON V.BODY).	week 0,week 4,week 8,week 20,week 32
Secondary	Change from baseline body mass index at 8 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.	week 0,week 4,week 8,week 20,week 32
Secondary	Change from baseline the body fat percentage at 8 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 a body composition analyzer (OMRON V.BODY).	week 0,week 8,week 32
Secondary	Change from baseline hip circumference at 8 weeks.	Hip circumference will be measured at the level of maximum posterior extension of the buttocks.	week 0,week 4,week 8,week 20,week 32
Secondary	Change from baseline waist-to-hip ratio at 8 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 ).	week 0,week 4,week 8,week 20,week 32
Secondary	Changes from baseline insulin resistance index at 8 weeks.	Examined with the blood sample.	week 0, week 8
Secondary	Changes from baseline blood fat at 8 weeks.	Examined with the blood sample.	week 0, week 8
Secondary	Changes from baseline blood pressure at 8 weeks	Both Systolic and diastolic blood pressure assessed by office and ambulatory blood pressure monitoring(mmHg).	week 0,week 4,week 8,week 32
Secondary	Changes from baseline the IWQOL - Lite scale score at 8 weeks	Quality of life was examined using the Impact of Weight on Quality of Life (IWQOL) questionnaire, which has a score range from 0(worst) to 100(best).	week 0,week 8,week 32
Secondary	Changes from baseline the Kessler 10 scale at 8weeks.	10 item self-report measure of psychological distress with five response categories (none of the time, a little of the time, some of the time, most of the time, all of the time). Scores range from 10 to 50; a higher score indicates more psychological distress.	week 0,week 8,week 32