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

October 11, 2023 updated by: Cheok Yean Chin, Universiti Putra Malaysia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Malaysia
    • Selangor
      • Serdang, Selangor, Malaysia, 43400
        • Universiti Putra Malaysia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

26 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Acupuncture plus diabetic routine care
Subjects will receive acupuncture treatment using press needles
Device: SEIRIN 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.
Placebo Comparator: Placebo plus diabetic routine care
Subjects are given placebo
Other: PYONEX Placebo
Subjects are given placebo on abdomen area; 10 sessions over 6 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fasting serum insulin
Time Frame: change from baseline fasting serum insulin at 7 weeks
Analyzed in μU/ml using heparin tube
change from baseline fasting serum insulin at 7 weeks
Fasting plasma glucose
Time Frame: change from baseline fasting plasma glucose at 7 weeks
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)
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).
change from baseline HOMA-IR at 7 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Health-related quality of life (HRQoL)
Time Frame: 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.
change from baseline HRQoL at 3-4 weeks
Health-related quality of life (HRQoL)
Time Frame: change from baseline HRQoL at 7 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.
change from baseline HRQoL at 7 weeks
Weight
Time Frame: change from baseline weight at 7 weeks
Changes is measured using digital scale TANITA weighing machine in kilograms.
change from baseline weight at 7 weeks
Body mass index
Time Frame: 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
change from baseline body mass index at 7 weeks
Waist circumference
Time Frame: change from baseline waist circumference at 7 weeks
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)
Time Frame: 7 weeks
Evaluated according to National Cancer Institute (2017) guidelines in terms of intensity (grade 1 - 5). Higher grades mean worst adverse event.
7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universiti Putra Malaysia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cheok Yean Chin, MSc, OMBAcC, Universiti Putra Malaysia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 27, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NCT04829045
  • JKEUPM-2018-294 (Other Identifier: JKEUPM of Universiti Putra Malaysia)
  • U1111-1219-3545 (Other Identifier: Universal Trial number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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