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

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ClinicalTrials.gov Identifier: NCT04829045
Recruitment Status : Recruiting
First Posted : April 2, 2021
Last Update Posted : July 20, 2021
Sponsor:
Information provided by (Responsible Party):
Cheok Yean Chin, 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Acupuncture Device: SEIRIN PYONEX Acupuncture Needles Other: PYONEX Placebo Not Applicable

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 and secondary outcomes of HRQoL, body mass index and waist circumference 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. Any adverse event will be recorded at every visit. The sequence generation and allocation will remain concealed from the patient and practitioner

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : May 27, 2021
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: Acupuncture plus diabetic routine care
Subjects will receive acupuncture treatment using press needles
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.

Placebo Comparator: Placebo plus diabetic routine care
Subjects are given placebo
Other: PYONEX Placebo
Subjects are given placebo on abdomen area; 10 sessions over 6 weeks.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04829045


Contacts
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Contact: Cheok Yean Chin, MSc, OMBAcC +60-03-9769 2300 gs44612@student.upm.edu.my

Locations
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Malaysia
Universiti Putra Malaysia Recruiting
Serdang, Selangor, Malaysia, 43400
Contact: Cheok Yean Chin, MSc, OMBAcC    +60-03 9769 2300    gs44612@student.upm.edu.my   
Sponsors and Collaborators
Universiti Putra Malaysia
Investigators
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Principal Investigator: Cheok Yean Chin, MSc, OMBAcC Universiti Putra Malaysia
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Responsible Party: Cheok Yean Chin, Principle Investigator, Universiti Putra Malaysia
ClinicalTrials.gov Identifier: NCT04829045    
Other Study ID Numbers: JKEUPM-2018-294 ( Other Identifier: JKEUPM of Universiti Putra Malaysia )
U1111-1219-3545 ( Other Identifier: Universal Trial number )
First Posted: April 2, 2021    Key Record Dates
Last Update Posted: July 20, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cheok Yean Chin, Universiti Putra Malaysia:
Type 2 diabetes mellitus
Acupuncture
Randomized controlled trial
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases