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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-27

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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

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Diabetes Mellitus, Type 2 Acupuncture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Acupuncture plus diabetic routine care

Subjects will receive acupuncture treatment using press needles

Group Type EXPERIMENTAL

SEIRIN PYONEX Acupuncture Needles

Intervention Type DEVICE

10 press needles (PYONEX ø0.20×1.5mm made by Seirin Corporation) will be placed on abdomen area; 10 sessions over 6 weeks.

Placebo plus diabetic routine care

Subjects are given placebo

Group Type PLACEBO_COMPARATOR

PYONEX Placebo

Intervention Type OTHER

Subjects are given placebo on abdomen area; 10 sessions over 6 weeks.

Interventions

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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.

Intervention Type DEVICE

PYONEX Placebo

Subjects are given placebo on abdomen area; 10 sessions over 6 weeks.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No