ObesityNCT06609200
Electro-Acupuncture for Obese Patients With Insulin Resistance
A study testing Acupuncture needles in people with Obesity and Insulin Resistance, run by Nanyang Technological University at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Obesity, Insulin Resistance
- What is being tested?
- Acupuncture needles
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSingapore
- Study dates
- 10 Oct 2024to 9 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Bleeding tendency
- Pregnant or lactating women
- Impaired hepatic or renal function
- Stroke or unable to exercise
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
Nanyang Technological University Traditional Chinese Medicine Clinic
Singapore, 637551
Zipan Lyu, Ph.D. candidate, 88649477, zipan001@e.ntu.edu.sg
linda Zhong, Ph.D.
About this study
Official title: 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.
- Conditions
- Obesity, Insulin Resistance
- Being tested
- Acupuncture needles
- Keywords
- electroacupuncture, obesity, insulin resistance
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture needlesDevice
The acupuncture needles and related equipment will have already received approval for routine Traditional Chinese Medicine (TCM) clinical practice in Singapore.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Acupuncture needles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From baseline to the end of treatment at week 8
Secondary outcomes (2)
Body Mass Index (BMI)
BMI = kg/m2
Measured: 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.
Measured: From baseline to the end of follow-up at week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start10 Oct 2024
- Primary completion9 Apr 2026 (estimated)
- Study completion9 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each patient will be scheduled for 16 treatment sessions, each lasting 30 minutes, twice a week over 8 weeks.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanyang Technological University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Zhong, Nanyang Technological University
- Investigators
- Linda Zhong, Ph.D., Principal investigator, nanyang technological university traditional chinese medicine clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609200
- Sponsor's protocol ID
- IRB-2024-165
- Status last verified
- Apr 2026
- First submitted
- 20 Sep 2024
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD sharing will be available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electro-acupuncture for the Obese Patient With Insulin Resistance: a Randomized Sham-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06609200
- Acronym / sponsor ID
- IRB-2024-165
- Conditions
- Obesity, Insulin Resistance
- Keywords
- electroacupuncture, obesity, insulin resistance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nanyang Technological UniversityUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 9 Apr 2026 (estimated)
- Study completion
- 9 Oct 2026 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Each patient will be scheduled for 16 treatment sessions, each lasting 30 minutes, twice a week over 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture group | Experimental | Device: Acupuncture needlesThe 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. |
| Sham acupuncture group | Sham comparator | Device: Acupuncture needlesThe 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture needlesThe acupuncture needles and related equipment will have already received approval for routine Traditional Chinese Medicine (TCM) clinical practice in Singapore. | Device | Electroacupuncture group, Sham acupuncture group |
Primary outcome
delta HOMA-IR
Time frame: From baseline to the end of treatment at week 8
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)
2 secondary outcomes
Body Mass Index (BMI)
Time frame: From enrollment to the end of follow-up at week 16
Waist-to-hip ratio
Time frame: From baseline to the end of follow-up at week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: Yes. IPD sharing will be available upon request.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Linda Zhong, Ph.D. principal investigator
nanyang technological university traditional chinese medicine clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture needles in people with Obesity and Insulin Resistance, run by Nanyang Technological University at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linda Zhong, Assoc prof (+65 8864 9477, linda.zhong@ntu.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
delta HOMA-IR (time frame: From baseline to the end of treatment at week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.