Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04829045
Recruitment Status : Recruiting
First Posted : April 2, 2021
Last Update Posted : July 30, 2021
Sponsor:
Information provided by (Responsible Party):
Cheok Yean Chin, Universiti Putra Malaysia

Tracking Information
First Submitted Date  ICMJE December 23, 2020
First Posted Date  ICMJE April 2, 2021
Last Update Posted Date July 30, 2021
Actual Study Start Date  ICMJE May 27, 2021
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2021)
  • Fasting serum insulin [ Time Frame: change from baseline fasting serum insulin at 7 weeks ]
    Analyzed in μU/ml using heparin tube
  • Fasting plasma glucose [ Time Frame: change from baseline fasting plasma glucose at 7 weeks ]
    Analyzed in mmol l-^1 using sodium fluoride tube
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2021)
  • 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.
  • 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.
  • Weight [ Time Frame: change from baseline weight at 7 weeks ]
    Changes is measured using digital scale TANITA weighing machine in kilograms.
  • 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
  • Waist circumference [ Time Frame: change from baseline waist circumference at 7 weeks ]
    Changes is measured using SECA measuring tape in centimeter
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Acupuncture as Adjunctive Therapy in Patients With Type 2 Diabetes Mellitus
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus, Type 2
  • Acupuncture
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Acupuncture plus diabetic routine care
    Subjects will receive acupuncture treatment using press needles
    Intervention: Device: SEIRIN PYONEX Acupuncture Needles
  • Placebo Comparator: Placebo plus diabetic routine care
    Subjects are given placebo
    Intervention: Other: PYONEX Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 30, 2021)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cheok Yean Chin, MSc, OMBAcC +60-03-9769 2300 gs44612@student.upm.edu.my
Listed Location Countries  ICMJE Malaysia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04829045
Other Study ID Numbers  ICMJE JKEUPM-2018-294 ( Other Identifier: JKEUPM of Universiti Putra Malaysia )
U1111-1219-3545 ( Other Identifier: Universal Trial number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cheok Yean Chin, Universiti Putra Malaysia
Study Sponsor  ICMJE Universiti Putra Malaysia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cheok Yean Chin, MSc, OMBAcC Universiti Putra Malaysia
PRS Account Universiti Putra Malaysia
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP