This study aims to determine the effect of acupuncture as an adjunctive therapy on homeostasis model assessment-insulin resistance (HOMA-IR) and health-related quality of life (HRQoL) in patients with type 2 diabetes mellitus.
This is a randomised, double-blind, placebo controlled and parallel design trial. Participants will be randomized to either acupuncture (n=30) or placebo (n=30) using a 1:1 ratio. The permuted blocks with a block size of 2 will be used. Both groups will continue with their routine diabetes care. Primary outcome of HOMA-IR will be measured at the time of recruitment (baseline) and after completion of 10 sessions (week 7) of the treatment. Secondary outcome of HRQOL will be measured at the time of recruitment (baseline), after completion of 5 sessions (week 3/4) and 10 sessions (week 7) of the treatment while outcomes of body mass index and waist circumference are measured at the time of recruitment (baseline) and after completion of 10 sessions (week 7) of the treatment. Any adverse event will be recorded at every visit. The sequence generation and allocation will remain concealed from the patient and practitioner.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
46
10 press needles (PYONEX ø0.20×1.5mm made by Seirin Corporation) will be placed on abdomen area; 10 sessions over 6 weeks.
Subjects are given placebo on abdomen area; 10 sessions over 6 weeks.
Universiti Putra Malaysia
Serdang, Selangor, Malaysia
Fasting serum insulin
Analyzed in μU/ml using heparin tube
Time frame: change from baseline fasting serum insulin at 7 weeks
Fasting plasma glucose
Analyzed in mmol l-\^1 using sodium fluoride tube
Time frame: change from baseline fasting plasma glucose at 7 weeks
Homeostasis model assessment- insulin resistance (HOMA-IR)
Fasting serum insulin and fasting plasma glucose will be combined to report HOMA-IR in unit \[fasting serum insulin (μU/ml)×fasting plasma glucose (mmol l-1)/22.5\](Mathews et al., 1985).
Time frame: change from baseline HOMA-IR at 7 weeks
Health-related quality of life (HRQoL)
Changes is assessed using World Health Organization Quality of Life Assessment: Brief Version (WHOQoL-BREF \[English/Malay\]) questionnaire which consists of 26 items and the scores range from 0-100. The higher the score, the better the HRQoL.
Time frame: change from baseline HRQoL at 3-4 weeks
Health-related quality of life (HRQoL)
Changes is assessed using World Health Organization Quality of Life Assessment: Brief Version (WHOQoL-BREF \[English/Malay\]) questionnaire which consists of 26 items and the scores range from 0-100. The higher the score, the better the HRQoL.
Time frame: change from baseline HRQoL at 7 weeks
Weight
Changes is measured using digital scale TANITA weighing machine in kilograms.
Time frame: change from baseline weight at 7 weeks
Body mass index
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Weight and height will be combined to report BMI in kg/m\^2. Height will be measured in centimeter using SECA body meter while weight will be measured in kilograms using digital scale TANITA weighing machine
Time frame: change from baseline body mass index at 7 weeks
Waist circumference
Changes is measured using SECA measuring tape in centimeter
Time frame: change from baseline waist circumference at 7 weeks
Incident of treatment adverse events in terms of intensity (grades 1 - 5)
Evaluated according to National Cancer Institute (2017) guidelines in terms of intensity (grade 1 - 5). Higher grades mean worst adverse event.
Time frame: 7 weeks