Clinical trial NCT04829045: Effects of Acupuncture as Adjunctive Therapy in Patients With Type 2 Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Acupuncture
Keywords: Type 2 diabetes mellitus
Acupuncture
Randomized controlled trial
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 46
Sex: ALL
Minimum age (years): 30
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Fasting serum insulin
timeFrame: change from baseline fasting serum insulin at 7 weeks
measure: Fasting plasma glucose
timeFrame: change from baseline fasting plasma glucose at 7 weeks
measure: Homeostasis model assessment- insulin resistance (HOMA-IR)
timeFrame: change from baseline HOMA-IR at 7 weeks
Secondary outcomes:
measure: Health-related quality of life (HRQoL)
timeFrame: change from baseline HRQoL at 3-4 weeks
measure: Health-related quality of life (HRQoL)
timeFrame: change from baseline HRQoL at 7 weeks
measure: Weight
timeFrame: change from baseline weight at 7 weeks
measure: Body mass index
timeFrame: change from baseline body mass index at 7 weeks
measure: Waist circumference
timeFrame: change from baseline waist circumference at 7 weeks
measure: Incident of treatment adverse events in terms of intensity (grades 1 - 5)
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Serdang
country: Malaysia
facility: Universiti Putra Malaysia
state: Selangor
Study officials:
affiliation: Universiti Putra Malaysia
name: Cheok Yean Chin, MSc, OMBAcC
role: PRINCIPAL_INVESTIGATOR
References: