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临床试验/NCT04791371
NCT04791371招募中不适用

Role of Microvascular Insulin Resistance and Cardiorespiratory Fitness Diabetes

University of Colorado, Denver2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年6月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
2
主要终点
Change in insulin sensitivity

研究概览

简要总结

The goal of this two-site grant proposal is to determine the role of the decreased insulin-mediated muscle perfusion found in type 2 diabetes in contributing to the development of cardiac and skeletal muscle dysfunction and subsequent functional exercise impairment. In addition, it is also our goal to determine whether exercise training attenuates insulin resistance and restores insulin-mediated perfusion to the heart and to skeletal muscle, leading to improved cardiac function and exercise performance.

详细描述

It is our goal to determine whether exercise training attenuates insulin resistance and restores insulin-mediated perfusion to the heart and to skeletal muscle, leading to improved cardiac function and exercise performance. Data from our two research teams suggest that the cardiac and skeletal muscle microvascular dysfunction present in people with type 2 diabetes contributes to limitations in cardiac and skeletal muscle function associated with impaired functional exercise capacity (a major predictor of CV and all-cause mortality). Insulin action is a potent predictor of the functional exercise capacity impairment in type 2 diabetes. The exact relationship between insulin action, cardiac and muscle dysfunction, cardiac and skeletal muscle perfusion and decreased functional exercise capacity in type 2 diabetes remains unclear.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Sedentary (defined as less than 1 hour per week of physical activity)
  • BMI: 25-40
  • Men and women with and without type 2 diabetes

排除标准

  • Documented cardiovascular disease
  • Uncontrolled hypertension: disease systolic blood pressure (SBP) > 150, diastolic blood pressure (DBP)> 110
  • Obstructive pulmonary disease or asthma
  • Peripheral neuropathy
  • Physical impairment that would limit exercise ability
  • Subjects taking beta blockers, calcium channel blockers, insulin, or Thiazolidinediones (TZD)
  • Current or past smoking within the last 1 years
  • Current tobacco use
  • Control HbA1c > 5.7, T2DM HbA1c > 9
  • Pregnant, nursing or hormonal therapy (other than contraceptives)
  • Peri or post-menopausal women
  • Type 1 diabetes
  • Hepatic or renal disease.

研究组 & 干预措施

Type 2 Diabetes

Experimental

Participants aged 30-55 with type 2 diabetes

干预措施: Cardiovascular exercise (Behavioral)

Healthy overweight control

Experimental

Participants aged 30-55 with BMI 25-40 without type 2 diabetes

干预措施: Cardiovascular exercise (Behavioral)

结局指标

主要结局

Change in insulin sensitivity

时间窗: Through study completion, approximately 4 months

The investigators will evaluate the changes in insulin sensitivity utilizing a euglycemic insulin clamp

Change in peak oxygen consumption (VO2)

时间窗: Through study completion, approximately 4 months

Subjects' peak oxygen consumption will be tested on a stationary bike before and after 15 weeks of exercise

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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