Electro-Acupuncture for Obese Patients with Insulin Resistance

Nanyang Technological University

Status: Not yet enrolling

Conditions: Insulin Resistance; Obesity

Treatments: Device: Acupuncture needles

Study type: Interventional

Funder types: Other

Identifiers

NCT06609200

IRB-2024-165

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women aged between 21 and 65 years old
• 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

• Diabetes mellitus
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Electroacupuncture group

Experimental group

Description:

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.

Treatment:

Device: Acupuncture needles

Sham acupuncture group

Sham Comparator group

Description:

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.

Treatment:

Device: Acupuncture needles