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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Acupuncture, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Device: SEIRIN PYONEX Acupuncture Needles
* Other: PYONEX Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture plus diabetic routine care<br>Subjects will receive acupuncture treatment using press needles | Device: SEIRIN PYONEX Acupuncture Needles<br>* 10 press needles (PYONEX ø0.20×1.5mm made by Seirin Corporation) will be placed on abdomen area; 10 sessions over 6 weeks.<br>|
| Placebo Comparator: Placebo plus diabetic routine care<br>Subjects are given placebo | Other: PYONEX Placebo<br>* Subjects are given placebo on abdomen area; 10 sessions over 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting serum insulin | Analyzed in μU/ml using heparin tube | change from baseline fasting serum insulin at 7 weeks | 
| Fasting plasma glucose | Analyzed in mmol l-^1 using sodium fluoride tube | 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). | change from baseline HOMA-IR at 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | change from baseline HRQoL at 7 weeks | 
| Weight | Changes is measured using digital scale TANITA weighing machine in kilograms. | change from baseline weight at 7 weeks | 
| Body mass index | 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 | change from baseline body mass index at 7 weeks | 
| Waist circumference | Changes is measured using SECA measuring tape in centimeter | 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. | 7 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes mellitus, Acupuncture, Randomized controlled trial