Recruiting NCT06609200
Electro-Acupuncture for Obese Patients With Insulin Resistance
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acupuncture needles.
- Who it may be relevant to
- Registry conditions: Obesity, Insulin Resistance. Basic parameters: 21 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Singapore
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Electro-acupuncture for the Obese Patient With Insulin Resistance: a Randomized Sham-controlled Clinical Trial
Overview
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.
Interventions
- Device Acupuncture needles
The acupuncture needles and related equipment will have already received approval for routine Traditional Chinese Medicine (TCM) clinical practice in Singapore.
Primary outcome measures
- delta HOMA-IR [Time frame: From baseline to the end of treatment at week 8]
Secondary outcome measures (2)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Singapore · 1 center
- Nanyang Technological University Traditional Chinese Medicine Clinic — Singapore
Identifiers
NCT: NCT06609200 · IRB-2024-165