Obesity
Conditions
Keywords
simple obesity, catgut implantation
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.
Interventions
DEVICEReal 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 .
DEVICEsham 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.
Sponsors
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
Hubei Hospital of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the rate of waistline reduction compared with baseline | week4 ,week8,week12,week16,week28,week40. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the rate of reduction of body mass index compared with baseline | week4 ,week8,week12,week16,week28,week40. | — |
| the rate of reduction of hipline compared with baseline | week4 ,week8,week12,week16,week28,week40. | — |
| the rate of reduction of waist-hip ratio compared with baseline | week4 ,week8,week12,week16,week28,week40. | — |
| the rate of reduction of percentage of body fat compared with baseline | week4 ,week8,week12,week16,week28,week40. | — |
| changes in IWQOL - Lite scale score compared with baseline | week4 ,week8,week12,week16,week28,week40. | — |
| changes in SF - 36 life quality scale score compared with baseline | week4 ,week16,week40. | — |
| changes in HAD scale score compared with baseline | week4 ,week16,week40. | — |
| the rate of reduction of weight compared with baseline | week4 ,week8,week12,week16,week28,week40. | — |
| changes in serum total cholesterol compared with baseline | week16. | — |
| changes in serum triglyceride compared with baseline | week16. | — |
| changes in low-density lipoprotein cholesterol (LDL-C) compared with baseline | week16. | — |
| changes in High-density lipoprotein cholesterol(HDL-C) compared with baseline | week16. | — |
| changes in fasting blood-glucose （FBG）compared with baseline | week16. | — |
| changes in fasting insulin ( FINS) compared with baseline | week16. | — |
| The adverse effects of catgut implantation at acupoints and as measured by number of participants with adverse events. | 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. |
| changes in self-esteem scale score compared with baseline | week4 ,week16,week40. | — |
Countries
China
Outcome results
None listed