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Catgut Implantation at Acupoints for the Treatment of Simple Obesity

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ClinicalTrials.gov Identifier: NCT02936973
Recruitment Status : Unknown
Verified April 2017 by Hubei Hospital of Traditional Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : October 18, 2016
Last Update Posted : April 21, 2017
Sponsor:
Collaborators:
State Administration of Traditional Chinese Medicine of the People's Republic of China
Dongzhimen Hospital, Beijing
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Information provided by (Responsible Party):
Hubei Hospital of Traditional Chinese Medicine

Tracking Information
First Submitted Date  ICMJE October 8, 2016
First Posted Date  ICMJE October 18, 2016
Last Update Posted Date April 21, 2017
Study Start Date  ICMJE November 2016
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2016)
the rate of waistline reduction compared with baseline [ Time Frame: week4 ,week8,week12,week16,week28,week40. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02936973 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2016)
  • the rate of reduction of weight compared with baseline [ Time Frame: week4 ,week8,week12,week16,week28,week40. ]
  • the rate of reduction of body mass index compared with baseline [ Time Frame: week4 ,week8,week12,week16,week28,week40. ]
  • the rate of reduction of hipline compared with baseline [ Time Frame: week4 ,week8,week12,week16,week28,week40. ]
  • the rate of reduction of waist-hip ratio compared with baseline [ Time Frame: week4 ,week8,week12,week16,week28,week40. ]
  • the rate of reduction of percentage of body fat compared with baseline [ Time Frame: week4 ,week8,week12,week16,week28,week40. ]
  • changes in IWQOL - Lite scale score compared with baseline [ Time Frame: week4 ,week8,week12,week16,week28,week40. ]
  • changes in SF - 36 life quality scale score compared with baseline [ Time Frame: week4 ,week16,week40. ]
  • changes in HAD scale score compared with baseline [ Time Frame: week4 ,week16,week40. ]
  • changes in self-esteem scale score compared with baseline [ Time Frame: week4 ,week16,week40. ]
  • changes in serum total cholesterol compared with baseline [ Time Frame: week16. ]
  • changes in serum triglyceride compared with baseline [ Time Frame: week16. ]
  • changes in low-density lipoprotein cholesterol (LDL-C) compared with baseline [ Time Frame: week16. ]
  • changes in High-density lipoprotein cholesterol(HDL-C) compared with baseline [ Time Frame: week16. ]
  • changes in fasting blood-glucose (FBG)compared with baseline [ Time Frame: week16. ]
  • changes in fasting insulin ( FINS) compared with baseline [ Time Frame: week16. ]
  • The adverse effects of catgut implantation at acupoints and as measured by number of participants with adverse events. [ Time Frame: from week 2 to week 16. ]
    The adverse effects of catgut implantation at acupoints include local swelling, pruritus, fever, festering and unbearable pain. In the event of an adverse effect during the trial, the patient should immediately contact the physician. All adverse effects should be promptly recorded.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Catgut Implantation at Acupoints for the Treatment of Simple Obesity
Official Title  ICMJE Clinical Effect of Catgut Implantation at Acupoints for the Treatment of Simple Obesity: a Multicentre Randomized Controlled Trial
Brief Summary The primary objective of this multicenter randomized controlled trial is to evaluate treatment effectiveness of intervening simple obesity people with catgut implantation at preferred acupoints, which excludes placebo effect; the secondary objective is to evaluate safety and superiority of treating simple obesity with catgut implantation at acupoints to provide high-level evidence for it clinically.
Detailed Description This randomized, double-blind sham-controlled clinical trial will be conducted at Hubei Provincial Hospital of TCM, Dongzhimen Hospital Beijing University of Chinese Medicine and the First Hospital of Hunan University of Chinese Medicine. This study includes the following time points: a treatment period of 16 weeks after screening and a follow-up period of 24 weeks. The total study period will be 40 weeks. All patients will be randomized into the real catgut implantation at acupoints group or the sham catgut implantation at acupoints group.The primary outcome measurement of this study is the rate of waistline reduction compared with baseline. The secondary outcome measurements are the rate of reduction of weight, BMI, hipline, WHR and PBF, and changes in the IWQOL-Lite compared with baseline. These parameters will be evaluated at week 0, week 4, week 8, week 12, week 16, week 28 and week 40. Changes in SF-36, HAD and SES compared with baseline will be evaluated at week 0, week 16 and week 40. SF-36 and IWQOL-Lite will be used to evaluate obese patient quality of life. HAD and SES will be used to evaluate psychological status. In addition, hepatorenal function, blood fat, liver bladder spleen colour ultrasound, FBG and insulin concentration will be used to evaluate whether catgut implantation at acupoints can improve the physiological function of obese patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Obesity
Intervention  ICMJE
  • Device: Real catgut implantation at acupoints
    1. Absorbable surgical suture will be embedded in acupoints as below. Group A :Zhigou (TE 6), Tianshu (ST25), Weishu (BL21), Zhongwan (CV12) and Zusanli (ST36); Group B :Quchi (LI11), Huaroumen (ST24), Pishu (BL20), Shuifen (CV9), and Fenglong (ST40). Each group will be used alternatively and treated once every 2 weeks.
    2. lifestyle intervention :Experienced nutritionists calculated every participant's basal metabolic rate,then designed a proper diet and exercise treatment for them. During the treatment, a diet and exercise diary will be distributed to the patients, and detailed guidance concerning their diet and exercise will be provided according to the diary. The patients should be encouraged to maintain the diet and exercise diary for at least 4 days per week .
  • Device: sham catgut implantation at acupoints

    Empty needles without catgut will be pushed into the chosen position as below :Group A :1 cun lateral from the Zhigou (TE 6), Tianshu (ST25), Weishu (BL21), Zhongwan (CV12) and Zusanli (ST36); Group B :1 cun lateral from the Quchi (LI11), Huaroumen (ST24), Pishu (BL20), Shuifen (CV9), and Fenglong (ST40).Those two groups of acupoints will ultimately be selected for alternative treatment. Each group will be used alternatively and treated once every 2 weeks.

    lifestyle intervention :It will be performed as the same as the real catgut implantation at acupoints group.

Study Arms  ICMJE
  • Experimental: Real catgut implantation
    Participants will receive real catgut implantation at acupoints plus lifestyle modification. Participants will receive catgut implantation treatment every two weeks to fulfill a 8-session treatment course.When the acupoints and surrounding skin are disinfected, an absorbable surgical suture of an appropriate length will be embedded into the muscular layer or subcutaneous tissue of the acupoints by the specified disposable embedding needles. The absorbable surgical suture then stimulated those points over a long period.
    Intervention: Device: Real catgut implantation at acupoints
  • Sham Comparator: sham catgut implantation
    Participants will receive sham catgut implantation at acupoints and lifestyle modification every two weeks to fulfill a 8-session treatment course.The operation process will be similar to that applied in the real catgut implantation group. Empty needles without catgut will be pushed into the chosen position, to a depth equivalent to that used for catgut implantation at acupoints. The frequency and duration were the the same as the catgut embedding group.
    Intervention: Device: sham catgut implantation at acupoints
Publications * Scheen AJ, Finer N, Hollander P, Jensen MD, Van Gaal LF, RIO-Diabetes Study Group. Efficacy and tolerability of rimonabant in overweight or obese patients with type 2 diabetes: a randomised controlled study. Lancet. 2006;368:1660-72. Preljevic VT, Østhus TB, Sandvik L, Opjordsmoen S, Nordhus IH, Os I, et al. Screening for anxiety and depression in dialysis patients: comparison of the Hospital Anxiety and Depression Scale and the Beck Depression Inventory. J Psychosom Res. 2012;73:139-44. Van Gaal LF, Rissanen AM, Scheen AJ, Ziegler O, Rössner S, RIO-Europe Study Group. Effects of the cannabinoid-1 receptor blocker rimonabant onweight reduction and cardiovascular risk factors in overweight patients: 1-year experience from the RIO-Europe study. Lancet. 2005;365:1389-97. Rosenberg M. Society and the adolescent self-image. Princeton, NJ: Princeton University Press; 1965. World Health Organization, Regional Office for the Western Pacific. The Asia-Pacific perspective: redefining obesity and its treatment. Sydney: Health Communications Australia; 2000. Astrup A, Madsbad S, Breum L, Jensen TJ, Kroustrup JP, Larsen TM. Effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trial. Lancet. 2008;372:1906-13. MacPherson H, White A, Cummings M, Jobst KA, Rose K, Niemtzow RC, et al. Standards for reporting interventions in controlled trials of acupuncture: the STRICTA recommendations. J Altern Complement Med. 2002;8:85 - 9. Ralph JL, Von Ah D, Scheett AJ, Hoverson BS, Anderson CM. Diet assessment methods: a guide for oncology nurses. Clin J Oncol Nurs. 2011;15:E114 - 21. James WP, Astrup A, Finer N, Hilsted J, Kopelman P, Rössner S, et al. Effect of sibutramine on weight maintenance after weight loss: a randomised trial. STORM Study Group. Sibutramine Trial of Obesity Reduction and Maintenance Lancet. 2000;356:2119-25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 14, 2016)
216
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria

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

  1. meeting the diagnosis standard for simple obesity in Redefinition and Processing of Obesity in Asia & Pacific Area released by WHO in February 2000;
  2. age: 18-45;
  3. BMI: 25≤BMI<30;
  4. waistline: males ≥95 cm; females ≥85 cm;
  5. smokers have not changed their smoking habits for at least 2 months;
  6. willing to accept the above-described intervention methods.

Exclusion criteria

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

  1. endocrine disease (such as polycystic ovarian syndrome, Cushing's Disease, and hypothyroidism, among others);
  2. gestational diabetes or uncontrolled hypertension (SBP ≥160 mmHg; DBP ≥100 mmHg) [23], or lung, heart, liver or kidney disease;
  3. nervous system disease or mental disorders, history of hospitalized depression, two instances of paralepsy or suicidal tendency;
  4. history of clinical diagnosis of an eating disorder , such as bulimia or cynorexia, anorexia; or weight changes greater than 5 kg in the previous 3 months;
  5. history of weight loss with surgery or a history of post-operative adhesion;
  6. having taken drugs with a known influence on weight or appetite in the previous 3 months, such as diet pills, corticosteroid drugs, anti-depression drugs, diazepam drugs, nonselective body antihistamine, nicotine replacements, or hypoglycaemic drugs, or planning to give up smoking and drinking;
  7. pregnancy, lactation, or planning to become pregnant within 40 weeks;
  8. received catgut implantation at acupoints;
  9. participated in clinical research on obesity in the previous 3 months ;
  10. protein allergy and scars;
  11. skin disease such as eczema and psoriasis;
  12. coagulation disorders, taking warfarin, heparin or other anticoagulant drugs;
  13. not cooperative or cannot maintain treatment during the study period.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02936973
Other Study ID Numbers  ICMJE 201507003
ChiCTR-IOR-16008384 ( Registry Identifier: A Multicenter Randomized Controlled Trial of Catgut Implantation at Acupoints for the Treatment of Simple Obesity )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: the data will be published in the form of public papers before May 2019 for public inquiries
Responsible Party Hubei Hospital of Traditional Chinese Medicine
Study Sponsor  ICMJE Hubei Hospital of Traditional Chinese Medicine
Collaborators  ICMJE
  • State Administration of Traditional Chinese Medicine of the People's Republic of China
  • Dongzhimen Hospital, Beijing
  • The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Investigators  ICMJE
Principal Investigator: Zhongyu Zhou, Professor Hubei Hospital of Traditional Chinese Medicine
PRS Account Hubei Hospital of Traditional Chinese Medicine
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP