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Completed

NCT Number: NCT04829045

Effects of Acupuncture as Adjunctive Therapy 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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Acupuncture Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universiti Putra Malaysia

Serdang, Selangor, 43400, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SEIRIN PYONEX Acupuncture Needles

Device

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

PYONEX Placebo

Other

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

Primary outcomes

  1. Fasting serum insulin

    Time frame: change from baseline fasting serum insulin at 7 weeks

    Analyzed in μU/ml using heparin tube

  2. Fasting plasma glucose

    Time frame: change from baseline fasting plasma glucose at 7 weeks

    Analyzed in mmol l-^1 using sodium fluoride tube

  3. Homeostasis model assessment- insulin resistance (HOMA-IR)

    Time frame: 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 outcomes

  1. Health-related quality of life (HRQoL)

    Time frame: change from baseline HRQoL at 3-4 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.

  2. Health-related quality of life (HRQoL)

    Time frame: 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.

  3. Weight

    Time frame: change from baseline weight at 7 weeks

    Changes is measured using digital scale TANITA weighing machine in kilograms.

  4. Body mass index

    Time frame: 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

  5. Waist circumference

    Time frame: change from baseline waist circumference at 7 weeks

    Changes is measured using SECA measuring tape in centimeter

  6. Incident of treatment adverse events in terms of intensity (grades 1 - 5)

    Time frame: 7 weeks

    Evaluated according to National Cancer Institute (2017) guidelines in terms of intensity (grade 1 - 5). Higher grades mean worst adverse event.

Sponsors and collaborators

Lead sponsor

Universiti Putra Malaysia

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 2, 2021
Registry last updated
Oct 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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