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Clinical Trials/NCT06609200
NCT06609200
Not yet recruiting
Not Applicable

Electro-acupuncture for the Obese Patient with Insulin Resistance: a Randomized Sham-controlled Clinical Trial

Nanyang Technological University0 sites60 target enrollmentOctober 10, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Nanyang Technological University
Enrollment
60
Primary Endpoint
HOMA-IR
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 10, 2024
End Date
October 9, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Linda Zhong

Assoc prof

Nanyang Technological University

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; 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.

Outcomes

Primary Outcomes

HOMA-IR

Time Frame: From enrollment to the end of follow up at 16 weeks

HOMA-IR = fasting insulin (ųU/mL)\* fasting glucose (mmol/L)/22.5

Secondary Outcomes

  • Body Mass Index (BMI)(From enrollment to the end of follow up at 16 weeks)
  • Waist-to-hip ratio(From enrollment to the end of follow up at 16 weeks)

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