Exercise Training in Type 2 Diabetes and Hypertension
Condition: Type 2 Diabetes; Hypertension
MeSH terms: Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The coexistence of diabetes and hypertension is damaging to cardiac and peripheral vascular
      structure and function. Although several health organizations endorse exercise training as a
      treatment for type 2 diabetes, most studies of exercise and diabetes have focused on
      controlling blood sugar but not on cardiovascular health. The aim of this study is to
      determine if exercise training reduces blood pressure and improves cardiovascular health in
      persons who have both type 2 diabetes and hypertension. An equal number of men and women will
      be enrolled, and another aim of the study is to examine gender differences in response to
      exercise training.
    

Detailed description: 
      Type 2 diabetes is associated with damage, dysfunction, and failure of various organs. The
      coexistence of diabetes and hypertension is particularly damaging to cardiac and peripheral
      vascular structure and function. These diseases, either alone or combined, result in
      increased left ventricular mass and wall thickness, left ventricular diastolic dysfunction,
      impaired endothelial vasodilator function, and increased vascular stiffness. Although several
      health organizations endorse exercise training as a therapeutic modality for type 2 diabetes,
      most studies of exercise and diabetes have focused on glycemic control but not on
      cardiovascular health. Although exercise lowers blood pressure in persons without diabetes,
      there are profound gaps in knowledge about the effects of exercise training on blood pressure
      and cardiovascular health in persons with type 2 diabetes. The primary specific aim of this
      study is to determine if exercise training reduces blood pressure in persons who have both
      type 2 diabetes and high normal blood pressure or mild hypertension prehypertension or Stage
      1 (mild) hypertension. Subjects will be randomized to 6-months of exercise training,
      consistent with established guidelines for diabetes and for hypertension, or to a usual care
      control group. The second specific aim is to identify the effects of exercise training on
      parameters of cardiac and peripheral vascular structure and function related to
      cardiovascular disease in diabetes and hypertension. We will assess left ventricular mass,
      left ventricular diastolic function, endothelial vasodilator function, and vascular stiffness
      using high-resolution ultrasound, Doppler echocardiography, and magnetic resonance imaging.
      We will also examine interleukin-6 and high-resolution C-reactive protein as novel risk
      factors for cardiovascular disease and diabetes to determine the effects of exercise training
      on the inflammatory process. Because exercise training improves fitness and may improve body
      composition and regional fat distribution, the associations of change in these parameters
      with change in blood pressure and cardiac and peripheral vascular structure and function will
      be analyzed. An equal number of men and women will be enrolled, and a third specific aim of
      the study is to examine gender differences in response to exercise training. This study will
      expand the scientific knowledge that defines exercise guidelines and will provide new insight
      into the mechanisms by which exercise reduces blood pressure and improves cardiovascular
      health in persons with type 2 diabetes and hypertension.
    

Intervention name(s): Exercise training for 6 months
Intervention type(s): Behavioral
Intervention description(s): Exercise 3 times/week for 6 months. Exercise consists of aerobic and resistance exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 2 diabetes; hypertension; exercise training; cardiac, peripheral; body composition; physical fitness; inflammation