Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| JKEUPM-2018-294 | Other Identifier | JKEUPM of Universiti Putra Malaysia | |
| U1111-1219-3545 | Other Identifier | Universal Trial number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture plus diabetic routine care | Experimental | Subjects will receive acupuncture treatment using press needles |
|
| Placebo plus diabetic routine care | Placebo Comparator | Subjects are given placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SEIRIN PYONEX Acupuncture Needles | Device | 10 press needles (PYONEX ø0.20×1.5mm made by Seirin Corporation) will be placed on abdomen area; 10 sessions over 6 weeks. |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Cheok Yean Chin, MSc, OMBAcC | Universiti Putra Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universiti Putra Malaysia | Serdang | Selangor | 43400 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37729132 | Derived | Cheok YC, Mohd Shariff Z, Chan YM, Ng OC, Lee PY. Effectiveness of acupuncture as adjunctive therapy in type 2 diabetic: Study protocol for a randomized controlled trial. PLoS One. 2023 Sep 20;18(9):e0284337. doi: 10.1371/journal.pone.0284337. eCollection 2023. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| PYONEX Placebo | Other | Subjects are given placebo on abdomen area; 10 sessions over 6 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 |
| D004700 | Endocrine System Diseases |