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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2; Acupuncture
• Interventions: Other: PYONEX Placebo; Device: SEIRIN PYONEX Acupuncture Needles

• Registration Number: NCT04829045
• Lead Sponsor: Universiti Putra Malaysia

Brief 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.

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 Timeline

• Study First Submitted: 2020-12-23
• Study First Submitted QC: 2021-03-30
• Study First Posted: 2021-04-02
• Study Start: 2021-05-27
• Status Verified: 2022-12
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Last Update Submitted: 2023-10-11
• Last Update Posted: 2023-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo plus diabetic routine care	PYONEX Placebo	Subjects are given placebo
Acupuncture plus diabetic routine care	SEIRIN PYONEX Acupuncture Needles	Subjects will receive acupuncture treatment using press needles

Primary Outcome Measures

Name	Time	Method
Fasting serum insulin	change from baseline fasting serum insulin at 7 weeks	Analyzed in μU/ml using heparin tube
Fasting plasma glucose	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)	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).

Secondary Outcome Measures

Name	Time	Method
Body mass index	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
Health-related quality of life (HRQoL)	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.
Weight	change from baseline weight at 7 weeks	Changes is measured using digital scale TANITA weighing machine in kilograms.
Waist circumference	change from baseline waist circumference at 7 weeks	Changes is measured using SECA measuring tape in centimeter
Incident of treatment adverse events in terms of intensity (grades 1 - 5)	7 weeks	Evaluated according to National Cancer Institute (2017) guidelines in terms of intensity (grade 1 - 5). Higher grades mean worst adverse event.

Trial Locations

Locations (1)

Universiti Putra Malaysia; 🇲🇾 Serdang, Selangor, Malaysia