Obesity, Insulin Resistance
Conditions
Keywords
electroacupuncture, obesity, insulin resistance
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.
Interventions
DEVICEAcupuncture needles
The acupuncture needles and related equipment will have already received approval for routine Traditional Chinese Medicine (TCM) clinical practice in Singapore.
Sponsors
Nanyang Technological University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
Each patient will be scheduled for 16 treatment sessions, each lasting 30 minutes, twice a week over 8 weeks.
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HOMA-IR | From enrollment to the end of follow up at 16 weeks | HOMA-IR = fasting insulin (ųU/mL)\* fasting glucose (mmol/L)/22.5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index (BMI) | From enrollment to the end of follow up at 16 weeks | BMI = kg/m2 |
| Waist-to-hip ratio | From enrollment to the end of follow up at 16 weeks | 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. |
Contacts
Primary ContactLinda Zhong, Assoc prof
Backup ContactZIPAN LYU
Outcome results
None listed