Electro-Acupuncture for Obese Patients with Insulin Resistance: a Randomized Sham-Controlled Trial

Not Applicable

Not yet recruiting

• Conditions: Obesity; Insulin Resistance

• Registration Number: NCT06609200
• Lead Sponsor: Nanyang Technological University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-20
• Study First Submitted QC: 2024-09-20
• Last Update Submitted: 2024-09-20
• Study First Posted: 2024-09-24
• Last Update Posted: 2024-09-24
• Study Start: 2024-10-10
• Primary Completion: 2026-04-09
• Study Completion: 2026-10-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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; treatment 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.