Electro-Acupuncture for Obese Patients With Insulin Resistance

NCT06609200 | Recruiting

• 1 other identifier: IRB-2024-165
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Insulin Resistance

Keywords

electroacupuncture; obesity; insulin resistance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Body Mass Index (BMI)

  From enrollment to the end of follow-up at week 16

• Waist-to-hip ratio

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

Study Arms (2)

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.

Device: Acupuncture needles

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.

Device: Acupuncture needles

Interventions

Acupuncture needles DEVICE

The acupuncture needles and related equipment will have already received approval for routine Traditional Chinese Medicine (TCM) clinical practice in Singapore.

Electroacupuncture group; Sham acupuncture group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanyang Technological University: lead

Study Sites (1)

Nanyang Technological University Traditional Chinese Medicine Clinic

Singapore, 637551, Singapore

RECRUITING

MeSH Terms

Conditions

Obesity; Insulin Resistance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Linda Zhong, Ph.D.

  nanyang technological university traditional chinese medicine clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda Zhong, Assoc prof

CONTACT

+65 8864 9477; linda.zhong@ntu.edu.sg

ZIPAN LYU

CONTACT

+65 88649477; zipan001@e.ntu.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc prof

Model Details: Each patient will be scheduled for 16 treatment sessions, each lasting 30 minutes, twice a week over 8 weeks.

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 24, 2024
• Study Start: October 10, 2024
• Primary Completion: April 9, 2026
• Study Completion (Estimated): October 9, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available within 7 years after completion of the clinical trial.
• 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.

Locations

SG (1)