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

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: Completed
• Conditions: Diabetes Mellitus, Type 2; Acupuncture
• Intervention / Treatment: Device: SEIRIN PYONEX Acupuncture Needles; Other: PYONEX Placebo

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: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Collaborators and Investigators

• Sponsor: Universiti Putra Malaysia
• Investigators: Principal Investigator: Cheok Yean Chin, MSc, OMBAcC, Universiti Putra Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: December 23, 2020
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (Actual): April 2, 2021

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Acupuncture; Randomized controlled trial; Type 2 diabetes mellitus
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID 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