Effects of Acupuncture as Adjunctive Therapy in Patients With Type 2 Diabetes Mellitus

The Effect of Acupuncture as Adjunctive Therapy on Homeostasis Model Assessment-insulin Resistance and Health Related Quality of Life in Patients With Type 2 Diabetes Mellitus

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.

10 press needles (PYONEX ø0.20×1.5mm made by Seirin Corporation) will be placed on abdomen area; 10 sessions over 6 weeks.

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).

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.

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.

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

Evaluated according to National Cancer Institute (2017) guidelines in terms of intensity (grade 1 - 5). Higher grades mean worst adverse event.

Inclusion Criteria: Fasting plasma glucose (FPG) ≥ 7.0 mmol/L [126 mg/dL] or HbA1c ≥ 6.5%. Subjects have had type 2 diabetes mellitus for more than one year Receive oral anti-diabetic agents on a stable dose over the previous 3 months. Exclusion Criteria: Under insulin therapy With other acute or chronic health problems Body mass index (BMI) ≥ 40.0 kg/m² Needle phobia or allergy to adhesive plaster Planning to move out from Malaysia within 4 months' Being pregnant, planning for pregnancy or lactating women