obesity
Conditions
Interventions
Treatment Group:Thread Embedding Therapy
Sponsors
Beijing Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Body-mass index: a. BMI = 28 kg/m2 or b. BMI = 24 kg/m2 with the presence of at least one of the following weight-related complications (treated or untreated): diabetes hypertension lipid metabolism disorders obstructive sleep apnea cardiovascular disease knee osteoarthritis hyperuricemia fatty liver; 2. Male or female age between 18 and 75 years at the time of signing informed consent; 3. No history of receiving thread embedding treatment; 4. History of at least one self-reported unsuccessful dietary effort and exercise program to lose body weight; 5. Informed consent obtained.
Exclusion criteria
Exclusion criteria: 1. A self-reported change in body weight = 5 kg within 90 days before screening; 2. Treatment with any medication for the indication of obesity within the past 90 days before Screening; 3. Previous or planned (during the trial period) obesity treatment with surgery or a bodyweight loss device. However the following were allowed: (1) liposuction and/or abdominoplasty if performed more than 1 year before screening; (2) lap banding if the band had been removed more than 1 year before screening; (3) intragastric balloon if the balloon had been removed more than 1 year before screening; or (4) duodenal-jejunal bypass sleeve if the sleeve had been removed more than 1 year before screening; 4. Have obesity induced by other endocrinologic disorders (for example Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example Melanocortin 4 Receptor deficiency or Prader Willi Syndrome); 5. Uncontrolled thyroid disease defined as thyroid stimulating hormone (TSH)>6.0 mIU/L or <0.35 mIU/L as measured by the central laboratory at screening; 6. Diagnosed with type 2 diabetes mellitus =180 days prior to the day of screening or those who have taken treatment with oral agents that were unstable (different drug(s) dose or dosing frequency) within the 90 days prior to screening; 7. Receipt of any acupuncture treatment for obesity within 90 days before screening; 8. Participation in any structured monitored weight-loss program within 90 days before screening; 9. Active inflammatory bowel disease celiac disease chronic pancreatitis or other disorder potentially causing malabsorption; 10. Any of the following severe cardiovascular diseases: myocardial infarction stroke heart failure symptomatic peripheral vascular diseases or hospitalization for unstable angina or transient ischemic attack within the last 6 months prior to screening; 11. History of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed; 12. Chronic respiratory neurological musculoskeletal or other disorders where in the judgement of the investigator participants would have unacceptable risk or difficulty in complying with the protocol; 13. Surgery scheduled for the duration of the trial except for minor surgical procedures in the opinion of the investigator; 14. Known or suspected abuse of alcohol or recreational drugs; 15. Female who was pregnant breast-feeding or intended to become pregnant or was of child-bearing potential and not using a highly effective contraceptive method; 16. Known or suspected hypersensitivity to trial product or related products; 17. Participation in another clinical trial within 90 days before screening; 18. Any disorder unwillingness or inability not covered by any of the other exclusion criteria which in the investigators opinion might have jeopardised the participants safety or compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| bodyweight; | — |
Secondary
| Measure | Time frame |
|---|---|
| fasting blood-glucose;blood pressure;total cholesterol;waistline;waist hip rate;low density lipoprotein;triglyceride;fMRI;body fat percentage;Three Factors Eating Questionaire;glycosylated hemoglobin A1c;Short Form 36;high-density lipoprotein;fasting insulin; | — |
Countries
China
Contacts
Public ContactBin Li
Beijing Hospital of Traditional Chinese Medicine
Outcome results
None listed