NCT04829045

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Universiti Putra Malaysia · Academic / Other
• Sex: All
• Age: 30 Years – 69 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 2
• Acupuncture

Interventions

Type	Name	Description
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.
OTHER	PYONEX Placebo	Subjects are given placebo on abdomen area; 10 sessions over 6 weeks.

Timeline

• Start date: 2021-05-27
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2021-04-02
• Last updated: 2023-10-12

Locations

1 site across 1 country: Malaysia