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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04829045
• Other study ID #: NCT04829045
• Secondary ID: JKEUPM-2018-294U
• Status: Completed
• Phase: N/A
• Start date: May 27, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2022
• Source: Universiti Putra Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Acupuncture
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
Malaysia	Universiti Putra Malaysia	Serdang	Selangor

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Putra Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting serum insulin	Analyzed in µU/ml using heparin tube	change from baseline fasting serum insulin at 7 weeks
Primary	Fasting plasma glucose	Analyzed in mmol l-^1 using sodium fluoride tube	change from baseline fasting plasma glucose at 7 weeks
Primary	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	Health-related quality of life (HRQoL)	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.	change from baseline HRQoL at 3-4 weeks
Secondary	Health-related quality of life (HRQoL)	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.	change from baseline HRQoL at 7 weeks
Secondary	Weight	Changes is measured using digital scale TANITA weighing machine in kilograms.	change from baseline weight at 7 weeks
Secondary	Body mass index	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	change from baseline body mass index at 7 weeks
Secondary	Waist circumference	Changes is measured using SECA measuring tape in centimeter	change from baseline waist circumference at 7 weeks
Secondary	Incident of treatment adverse events in terms of intensity (grades 1 - 5)	Evaluated according to National Cancer Institute (2017) guidelines in terms of intensity (grade 1 - 5). Higher grades mean worst adverse event.	7 weeks