Diabetes Mellitus, Type 2NCT04829045
Effects of Acupuncture as Adjunctive Therapy in Patients With Type 2 Diabetes Mellitus
A study testing SEIRIN PYONEX Acupuncture Needles in people with Diabetes Mellitus, Type 2 and Acupuncture, run by Universiti Putra Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 69 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Acupuncture
- What is being tested?
- SEIRIN PYONEX Acupuncture Needles
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteMalaysia
- Study dates
- 27 May 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2, Acupuncture
- Being tested
- SEIRIN PYONEX Acupuncture Needles, PYONEX Placebo
- Keywords
- Type 2 diabetes mellitus, Acupuncture, Randomized controlled trial
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEIRIN PYONEX Acupuncture NeedlesDevice
10 press needles (PYONEX ø0.20×1.5mm made by Seirin Corporation) will be placed on abdomen area; 10 sessions over 6 weeks.
PYONEX PlaceboOther
Subjects are given placebo on abdomen area; 10 sessions over 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture plus diabetic routine care | Experimental | Subjects will receive acupuncture treatment using press needles Receives: Device: SEIRIN PYONEX Acupuncture Needles |
| Placebo plus diabetic routine care | Placebo comparator | Subjects are given placebo Receives: Other: PYONEX Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting serum insulin
Analyzed in μU/ml using heparin tube
Measured: change from baseline fasting serum insulin at 7 weeks
Fasting plasma glucose
Analyzed in mmol l-^1 using sodium fluoride tube
Measured: 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).
Measured: change from baseline HOMA-IR at 7 weeks
Secondary outcomes (6)
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.
Measured: 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.
Measured: change from baseline HRQoL at 7 weeks
Weight
Changes is measured using digital scale TANITA weighing machine in kilograms.
Measured: 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
Measured: change from baseline body mass index at 7 weeks
Waist circumference
Changes is measured using SECA measuring tape in centimeter
Measured: 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.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start27 May 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheok Yean Chin, Universiti Putra Malaysia
- Investigators
- Cheok Yean Chin, MSc, OMBAcC, Principal investigator, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829045
- Sponsor's protocol ID
- NCT04829045
- Other IDs
- JKEUPM-2018-294, U1111-1219-3545
- Status last verified
- Dec 2022
- First submitted
- 23 Dec 2020
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37729132
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04829045
- Acronym / sponsor ID
- NCT04829045
- Conditions
- Diabetes Mellitus, Type 2, Acupuncture
- Keywords
- Type 2 diabetes mellitus, Acupuncture, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 27 May 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 2 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture plus diabetic routine care | Experimental | Device: SEIRIN PYONEX Acupuncture NeedlesSubjects will receive acupuncture treatment using press needles |
| Placebo plus diabetic routine care | Placebo comparator | Other: PYONEX PlaceboSubjects are given placebo |
Who may qualify
- Ages
- 30 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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'
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SEIRIN PYONEX Acupuncture Needles10 press needles (PYONEX ø0.20×1.5mm made by Seirin Corporation) will be placed on abdomen area; 10 sessions over 6 weeks. | Device | Acupuncture plus diabetic routine care |
| PYONEX PlaceboSubjects are given placebo on abdomen area; 10 sessions over 6 weeks. | Other | Placebo plus diabetic routine care |
Primary outcome
Fasting serum insulin
Time frame: change from baseline fasting serum insulin at 7 weeks
Analyzed in μU/ml using heparin tube
Fasting plasma glucose
Time frame: 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)
Time frame: 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).
6 secondary outcomes
Health-related quality of life (HRQoL)
Time frame: change from baseline HRQoL at 3-4 weeks
Health-related quality of life (HRQoL)
Time frame: change from baseline HRQoL at 7 weeks
Weight
Time frame: change from baseline weight at 7 weeks
Body mass index
Time frame: change from baseline body mass index at 7 weeks
Waist circumference
Time frame: change from baseline waist circumference at 7 weeks
Incident of treatment adverse events in terms of intensity (grades 1 - 5)
Time frame: 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Derived from this study: PubMed 37729132Cheok 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheok Yean Chin, MSc, OMBAcC principal investigator
Universiti Putra Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SEIRIN PYONEX Acupuncture Needles in people with Diabetes Mellitus, Type 2 and Acupuncture, run by Universiti Putra Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting serum insulin (time frame: change from baseline fasting serum insulin at 7 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04829045, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.