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

University of Putra Malaysia (UPM)

Status: Completed

Conditions: Acupuncture; Diabetes Mellitus, Type 2

Treatments: Device: SEIRIN PYONEX Acupuncture Needles; Other: PYONEX Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04829045

JKEUPM-2018-294 (Other Identifier)

U1111-1219-3545 (Other Identifier)

NCT04829045

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 30 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups, including a placebo group

Acupuncture plus diabetic routine care

Experimental group

Description:

Subjects will receive acupuncture treatment using press needles

Treatment:

Device: SEIRIN PYONEX Acupuncture Needles

Placebo plus diabetic routine care

Placebo Comparator group

Description:

Subjects are given placebo

Treatment:

Other: PYONEX Placebo