Electro-Acupuncture for Obese Patients With Insulin Resistance

Electro-acupuncture for the Obese Patient With Insulin Resistance: a Randomized Sham-controlled Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Insulin Resistance
• Intervention / Treatment: Device: Acupuncture needles

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Linda Zhong, Assoc prof; Phone Number: +65 8864 9477; Email: linda.zhong@ntu.edu.sg
• Study Contact Backup: Name: ZIPAN LYU; Phone Number: +65 88649477; Email: zipan001@e.ntu.edu.sg

Study Locations

• Singapore
  • Singapore, Singapore, 637551
    • Recruiting
    • Nanyang Technological University Traditional Chinese Medicine Clinic
    • Contact: Zipan Lyu, Ph.D. candidate; Phone Number: 88649477; Email: zipan001@e.ntu.edu.sg
    • Principal Investigator: linda Zhong, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Acupuncture needles; The acupuncture needles and related equipment will have already received approval for routine Traditional Chinese Medicine (TCM) clinical practice in Singapore.
Sham Comparator: 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.	Device: Acupuncture needles; The acupuncture needles and related equipment will have already received approval for routine Traditional Chinese Medicine (TCM) clinical practice in Singapore.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	From baseline to the end of follow-up at week 16

Collaborators and Investigators

• Sponsor: Nanyang Technological University
• Investigators: Principal Investigator: Linda Zhong, Ph.D., Nanyang Technological University Traditional Chinese Medicine Clinic

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2024
• Primary Completion (Estimated): April 9, 2026
• Study Completion (Estimated): October 9, 2026

Study Registration Dates

• First Submitted: September 20, 2024
• First Submitted That Met QC Criteria: September 20, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: obesity; insulin resistance; electroacupuncture
• Additional Relevant MeSH Terms: Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Hyperinsulinism; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Insulin Resistance
• Other Study ID Numbers: IRB-2024-165

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD sharing will be available upon request.
• IPD Sharing Time Frame: Data will become available within 7 years after completion of the clinical trial.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No