Electro-Acupuncture for Obese Patients with Insulin Resistance

NCT ID: NCT06609200

Last Updated: 2024-09-25

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-10

Study Completion Date

2026-10-09

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Each patient will be scheduled for 16 treatment sessions, each lasting 30 minutes, twice a week over 8 weeks.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

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.

Group Type EXPERIMENTAL

Acupuncture needles

Intervention Type DEVICE

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.

Group Type SHAM_COMPARATOR

Acupuncture needles

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanyang Technological University

OTHER

Sponsor Role lead

Responsible Party

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Linda Zhong

Assoc prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Linda Zhong, Assoc prof

Role: CONTACT

+65 8864 9477

ZIPAN LYU

Role: CONTACT

+65 88649477

Other Identifiers

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IRB-2024-165

Identifier Type: -

Identifier Source: org_study_id

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