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This clinical trial aims to evaluate the efficacy and safety of electro-acupuncture for obese patients with insulin resistance. 60 participants will be randomized and allocated to either the electro-acupuncture arm or the sham acupuncture arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electroacupuncture group | Experimental | The WHO Standardized Acupuncture Points Location [2] will be used to identify the location of these acupoints, Tianshu(ST-25), Daheng(SP-15), Daimai(GB-24), Qihai(CV-6), Zhongwan(CV-12), Zusanli (ST-36), Fenlong(ST-40), and Sanyinjiao(SP-6). After sterilizing the skin, sterile adhesive pads will be pasted on acupoints first, and then needles of size 0.30*75 mm will be inserted into the acupoints to a depth of 50 mm outward and upward slightly. Needles will be lifted, thrust, and twirled evenly 3 times to achieve "de-qi". Paired electrodes of the EA apparatus will be attached transversely to the acupoint respectively with a continuous wave of 50 Hz and a current intensity of 1-5 mA (preferably with the skin around the acupoints shivering mildly without pain) for 30 min. Patients will be treated with electroacupuncture 2 sessions per week over 8 consecutive weeks, 16 sessions for each patient. |
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| Sham acupuncture group | Sham Comparator | The sham electro-acupuncture group (SEA) penetrates acupuncture on non-acupuncture points (1 cm away from the acupuncture point and meridian). The same type of acupuncture needles will be used for SEA with the exact skin sterilization method. All acupuncture points will be needled perpendicularly with a guide tube. Insertion depth will be approximately 50 mm, depending on the location of individual points. Each point will be connected to a sham electro-stimulator (showing a continuous wave at a frequency of 30 Hz but without actual stimulation). All needles will be removed after 30 min of needle retention. Patients will be treated with sham electroacupuncture 2 sessions per week over 8 consecutive weeks, 16 sessions for each patient in total. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture needles | Device | The acupuncture needles and related equipment will have already received approval for routine Traditional Chinese Medicine (TCM) clinical practice in Singapore. |
| Measure | Description | Time Frame |
|---|---|---|
| delta HOMA-IR | delta HOMA-IR = (end-of-treatment fasting insulin (ųU/mL)* end-of-treatment fasting glucose (mmol/L)/22.5) - (baseline fasting insulin (ųU/mL)* baseline fasting glucose (mmol/L)/22.5) | From baseline to the end of treatment at week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index (BMI) | BMI = kg/m2 | From enrollment to the end of follow-up at week 16 |
| Waist-to-hip ratio | The waist-hip ratio or waist-to-hip ratio (WHR) is the dimensionless ratio of the circumference of the waist to that of the hips. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linda Zhong, Assoc prof | Contact | +65 8864 9477 | linda.zhong@ntu.edu.sg | |
| ZIPAN LYU | Contact | +65 88649477 | zipan001@e.ntu.edu.sg |
| Name | Affiliation | Role |
|---|---|---|
| Linda Zhong, Ph.D. | nanyang technological university traditional chinese medicine clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanyang Technological University Traditional Chinese Medicine Clinic | Recruiting | Singapore | 637551 | Singapore |
IPD sharing will be available upon request.
Data will become available within 7 years after completion of the clinical trial.
Individual participant data (IPD) will be made available to qualified researchers upon request. To access the data, researchers must submit a formal request, which will be reviewed and approved by the data-sharing committee. Data access will be granted for research purposes only and will require adherence to data use agreements and ethics guidelines.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Each patient will be scheduled for 16 treatment sessions, each lasting 30 minutes, twice a week over 8 weeks.
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After a participant's eligibility is confirmed, a randomization number that corresponds to the group allocation will be provided to the acupuncturist. The clinical assessor and participants will be blinded to the allocation.
| From baseline to the end of follow-up at week 16 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |