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临床试验/NCT02551900
NCT02551900已完成不适用

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

Chulalongkorn University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2014年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
Change from baseline in glycemic control

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

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

研究组 & 干预措施

Warm water exercise & Cold water exercise

Experimental

干预措施: Warm water exercise (Other)

Warm water exercise & Cold water exercise

Experimental

干预措施: Cold water exercise (Other)

Warm water exercise & Land cycling exercise

Active Comparator

干预措施: Warm water exercise (Other)

Warm water exercise & Land cycling exercise

Active Comparator

干预措施: Land based cycling exercise (Other)

结局指标

主要结局

Change from baseline in glycemic control

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • Change from baseline in physical fitness(Baseline, 12 weeks)
  • Change from baseline in blood chemistry(Baseline, 12 weeks)
  • Change from baseline in Peripheral arterial stiffness(Baseline, 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Assoc. Prof. Dr.Daroonwan Suksom

Faculty of Sport Science

Chulalongkorn University

研究点 (1)

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