A Comparison of the Effect of Warm and Cold Water Exercise Training on Vascular Function in Type 2 Diabetic Patients

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Other: Warm water exercise; Other: Cold water exercise; Other: Land based cycling exercise

• Registration Number: NCT02551900
• Lead Sponsor: Chulalongkorn University

Brief Summary

Warm water based cycling exercise training would more favorable than cold water based cycling exercise training and land based cycling exercise in vascular function in type 2 diabetic patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-01
• Primary Completion: 2015-09-15
• Study First Submitted: 2015-09-15
• Study First Submitted QC: 2015-09-15
• Study First Posted: 2015-09-16
• Study Completion: 2016-12-15
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-03
• Last Update Posted: 2018-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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
Warm water exercise & Cold water exercise	Cold water exercise	-
Warm water exercise & Cold water exercise	Warm water exercise	-
Warm water exercise & Land cycling exercise	Warm water exercise	-
Warm water exercise & Land cycling exercise	Land based cycling exercise	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in glycemic control	Baseline, 12 weeks	The glycemic control will be quantified using blood samples. Fasting blood glucose, HbA1c, insulin, homeostasis model assessment of insulin resistance (HOMA-IR) and C-reactive protein will be measured with standard procedures at the clinical laboratory (N health Lab, Samitivej, Sriracha, Thailand). Homeostasis model assessment (HOMA-IR will be calculated by using equation of \[Fasting glucose (mg/dL) × Insulin level (uU/mL) / 405\].
Change from baseline in vascular reactivity	Baseline, 12 weeks	Vascular reactivity or brachial and popliteal artery flow-mediated dilatation (FMD) will be assessed with the ultrasound equipment (CX50, Philips, USA), using the blood occlusion technique on the right forearm and lower leg. The brachial artery and the popliteal artery will be imaged above the antecubital fossa in the longitudinal plane and proximal slightly above the popliteal fossa. Brachial FMD will be measured at baseline 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. While popliteal FMD will be measured at baseline and the cuff will be positioned on the lower right leg below the knee will be inflated to 250 mmHg 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 or popliteal artery diameter at baseline, D2 is the maximal post-occlusion brachial or popliteal artery diameter.
Change from baseline in cutaneous blood flow	Baseline, 12 weeks	Cutaneous blood flow will be determined by laser Doppler Flowmetry (DRT4, Moore Instrument, UK). Laser Doppler Flowmetry probes will be attached to the dorsum of middle fingertip and the dorsum of the foot. The occlusion cuffs will be placed around left middle upper arm and calf were inflated to a pressure of 50 mmHg above the systolic pressure and will be remained inflated for 3 minutes, after which it will be rapidly released, producing a brief high-flow state resulting in artery dilation due to increase shear stress. The peak Laser Doppler Flux (peak LDF) and after 5 min occlusion period will be recorded.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in physical fitness	Baseline, 12 weeks	Pulmonary function will be measured by spirometer ((MIR-Spirobank G)
Change from baseline in Peripheral arterial stiffness	Baseline, 12 weeks	Pulse wave velocity (brachial-ankle PWV) measurement will be assessed using Omron Colin VP1000 for measuring.
Change from baseline in blood chemistry	Baseline, 12 weeks	C-reactive protein will be measured with standard procedures at the clinical laboratory (N health Lab, Samitivej, Sriracha, Thailand).

Trial Locations

Locations (1)

Laemchabang stadium, Sukhumvit Rd; 🇹🇭 Si Racha, Chon Buri, Thailand