Acupuncture, Diabetes Mellitus, Type 2
Conditions
Keywords
Type 2 diabetes mellitus, Acupuncture, Randomized controlled trial
Brief summary
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.
Detailed description
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.
Interventions
DEVICESEIRIN PYONEX Acupuncture Needles
10 press needles (PYONEX ø0.20×1.5mm made by Seirin Corporation) will be placed on abdomen area; 10 sessions over 6 weeks.
OTHERPYONEX Placebo
Subjects are given placebo on abdomen area; 10 sessions over 6 weeks.
Sponsors
Universiti Putra Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
30 Years to 69 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting serum insulin | change from baseline fasting serum insulin at 7 weeks | Analyzed in μU/ml using heparin tube |
| Fasting plasma glucose | change from baseline fasting plasma glucose at 7 weeks | Analyzed in mmol l-\^1 using sodium fluoride tube |
| Homeostasis model assessment- insulin resistance (HOMA-IR) | change from baseline HOMA-IR at 7 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Waist circumference | change from baseline waist circumference at 7 weeks | Changes is measured using SECA measuring tape in centimeter |
| Health-related quality of life (HRQoL) | change from baseline HRQoL at 3-4 weeks | 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. |
| Incident of treatment adverse events in terms of intensity (grades 1 - 5) | 7 weeks | Evaluated according to National Cancer Institute (2017) guidelines in terms of intensity (grade 1 - 5). Higher grades mean worst adverse event. |
| Weight | change from baseline weight at 7 weeks | Changes is measured using digital scale TANITA weighing machine in kilograms. |
| Body mass index | change from baseline body mass index at 7 weeks | 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 |
Countries
Malaysia
Outcome results
None listed