The Effect of Walking Meditation Training on Glycemic Control and Vascular Function in Patients With Type 2 Diabetes

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Other: Walking Meditation; Other: No exercise; Other: Walking

• Registration Number: NCT02123901
• Lead Sponsor: Chulalongkorn University

Brief Summary

Walking Meditation training would yield more favorable adaptations than walking alone in improving glycemic control and vascular function in patients with type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-08
• Study Start: 2013-12
• Study First Submitted: 2014-04-18
• Study First Submitted QC: 2014-04-25
• Study First Posted: 2014-04-28
• Primary Completion: 2014-10
• Study Completion: 2015-02
• Last Update Submitted: 2015-09-15
• Last Update Posted: 2015-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• The inclusion criteria included type 2 diabetes (as defined by the American Diabetes Association), a baseline glycosylated hemoglobin (HbA1c) value of 7-9%, and no previous exercise training in the past 6 months. All participants were free from diabetic nephropathy, diabetic retinopathy, severe diabetic neurophathy, severe cardiovascular and cerebrovascular diseases.

Exclusion Criteria

• Participants were excluded if they dropped out or completed less than 80% of the training schedule.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Walking meditation & Walking	Walking Meditation	-
Walking meditation & No exercise	Walking Meditation	-
Walking meditation & No exercise	No exercise	-
Walking meditation & Walking	Walking	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in glycemic control	Baseline, Week 12	The glycemic control will be quantified using blood samples. Fasting blood glucose, HbA1c, and insulin will be measured with standard procedures at the clinical laboratory (Bria Lab, Bangkok, Thailand).Homeostasis model assessment (HOMA), the parameter for insulin resistance, will be calculated by using equation of \[Fasting glucose (mg/dL) × Insulin level (uU/mL) / 405\].
Change from baseline in vascular reactivity	baseline, week 12	Vascular reactivity or brachial artery flow-mediated dilatation (FMD) will be assessed with the ultrasound equipment (CX50, Philips, USA), using the blood occlusion technique on the right forearm. The brachial artery will be imaged above the antecubital fossa in the longitudinal plane. Baseline data will be monitored and the cuff placed around the right forearm will be inflated to 50 mmHg above systolic blood pressure for 5 minutes and then deflated for 5 minutes of recovery. FMD will be calculated from the formula FMD=(D2-D1)x100/D1 when D1 is the brachial artery diameter at baseline, D2 is the maximal post-occlusion brachial artery diameter

Secondary Outcome Measures

Name	Time	Method
Change from baseline in stress indicators	Baseline, Week 12	* Plasma cortisol will be measured with standard procedures at the certified clinical laboratory (BRIA Lab, Bangkok, Thailand).; * Heart rate variability (HRV) will be measured using the Heart rate variability analyzer SA-3000P, Medicore Co.,Ltd, Korea
Change from baseline in physical fitness	Baseline, Week 12	* Body composition will be measured using Body Composition Analyzer (Model ioi 353, Jawon Medical Co. Ltd., Korea).; * Maximal oxygen consumption (VO2max) will be assessed by Modified Bruce Protocol for treadmill test with Stationary Gas Analyzer (Vmax™ Encore 29 system, Yorba Linda, CA).; * Lower muscle strength will be measured with back and leg dynamometer.
Change from baseline in Peripheral arterial stiffness	Baseline, Week 12	Pulse wave velocity measurement will be assessed with MD6 bidirectional transcutaneous Doppler probe (Hokanson, Bellevue, WA, USA). All subjects were monitored with an EKG and PWV measurements in the computer and used as timing markers for PWV identification.
Change from baseline in ankle-brachial index.	Baseline, Week 12	Ankle-brachial index will be evaluated with a manual MD6 bidirectional transcutaneous Doppler probe (Hokanson, Bellevue, WA, USA) and will be calculated by dividing the highest ankle systolic blood pressure by the highest brachial systolic blood pressure.
Change from baseline in blood chemistry	Baseline, Week 12	* Interleukin-6 (IL-6) will be measured in plasma samples with the ELISA kit (Human IL-6 high sensitivity ELISA, eBioscience, Austria).; * Nitric oxide (NO) will be measured in plasma samples with the commercial assay kit (Colorimetric nitric oxide assay kit, PromoKine, Germany).

Trial Locations

Locations (1)

The Primary Health Promoting Hospital; 🇹🇭 Prapadang, Samut Prakan, Thailand