Electro-Acupuncture for Obese Patients with Insulin Resistance
NCT ID: NCT06609200
Last Updated: 2024-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2024-10-10
2026-10-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Electroacupuncture group
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.
Acupuncture needles
The acupuncture needles and related equipment will have already received approval for routine Traditional Chinese Medicine (TCM) clinical practice in Singapore.
Sham acupuncture group
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.
Acupuncture needles
The acupuncture needles and related equipment will have already received approval for routine Traditional Chinese Medicine (TCM) clinical practice in Singapore.
Interventions
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Acupuncture needles
The acupuncture needles and related equipment will have already received approval for routine Traditional Chinese Medicine (TCM) clinical practice in Singapore.
Eligibility Criteria
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Inclusion Criteria
* BMI ≥ 25 kg/m2
* HOMA-IR ≥ 2.14, (HOMA-IR = fasting insulin (ųU/mL)\* fasting glucose (mmol/L)/22.5)
* Not receiving any other weight control measures or any medical and/or drug history in the last 3 months
Exclusion Criteria
* Treating with drugs that may affect insulin sensitivity
* Changes 10% of usual body weight in the previous 6 months weight
* Endocrine diseases, including thyroid disorder, pituitary disorder, sex gland disorder, etc.
* Heart diseases, including arrhythmia, heart failure, and myocardial infarction, participants with pacemakers
* Allergy and immunology diseases
* Bleeding tendency
* Pregnant or lactating women
* Impaired hepatic or renal function
* Stroke or unable to exercise
21 Years
65 Years
ALL
No
Sponsors
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Nanyang Technological University
OTHER
Responsible Party
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Linda Zhong
Assoc prof
Central Contacts
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Other Identifiers
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IRB-2024-165
Identifier Type: -
Identifier Source: org_study_id
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