NCT04829045

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 2, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 27, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

October 12, 2023

Status Verified

December 1, 2022

Enrollment Period

1.6 years

First QC Date

December 23, 2020

Last Update Submit

October 11, 2023

Conditions

Diabetes Mellitus, Type 2Acupuncture

Keywords

Type 2 diabetes mellitusAcupunctureRandomized controlled trial

Outcome Measures

Primary Outcomes (3)

  • Fasting serum insulin

    Analyzed in μU/ml using heparin tube

    change from baseline fasting serum insulin at 7 weeks

  • Fasting plasma glucose

    Analyzed in mmol l-\^1 using sodium fluoride tube

    change from baseline fasting plasma glucose at 7 weeks

  • Homeostasis model assessment- insulin resistance (HOMA-IR)

    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).

    change from baseline HOMA-IR at 7 weeks

Secondary Outcomes (6)

  • Health-related quality of life (HRQoL)

    change from baseline HRQoL at 3-4 weeks

  • Health-related quality of life (HRQoL)

    change from baseline HRQoL at 7 weeks

  • Weight

    change from baseline weight at 7 weeks

  • Body mass index

    change from baseline body mass index at 7 weeks

  • Waist circumference

    change from baseline waist circumference at 7 weeks

  • +1 more secondary outcomes

Study Arms (2)

Acupuncture plus diabetic routine care

EXPERIMENTAL

Subjects will receive acupuncture treatment using press needles

Device: SEIRIN PYONEX Acupuncture Needles

Placebo plus diabetic routine care

PLACEBO COMPARATOR

Subjects are given placebo

Other: PYONEX Placebo

Interventions

SEIRIN PYONEX Acupuncture NeedlesDEVICE

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

Acupuncture plus diabetic routine care
PYONEX PlaceboOTHER

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

Placebo plus diabetic routine care

Eligibility Criteria

Age30 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiti Putra Malaysia

Serdang, Selangor, 43400, Malaysia

Location

Related Publications (1)

  • Cheok YC, Mohd Shariff Z, Chan YM, Ng OC, Lee PY. Effectiveness of acupuncture as adjunctive therapy in type 2 diabetic: Study protocol for a randomized controlled trial. PLoS One. 2023 Sep 20;18(9):e0284337. doi: 10.1371/journal.pone.0284337. eCollection 2023.

    PMID: 37729132DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Cheok Yean Chin, MSc, OMBAcC

    Universiti Putra Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

December 23, 2020

First Posted

April 2, 2021

Study Start

May 27, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

October 12, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)