View Clinical Trial (Medical Research Study)
Exercise Training in Type 2 Diabetes and Hypertension
| City: |
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Baltimore |
| State: |
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Maryland |
| Zip Code: |
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21224 |
| Conditions: |
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Diabetes Mellitus, Type 2 - Hypertension |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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Inclusion Criteria:
ages 40-65 years type 2 diabetes BP between SBP 120-159 or DBP 80-99 mm Hg sedentary
Exclusion Criteria:
cardiovascular disease abnormal exercise stress test smoking insulin use major illnesses
that would preclude exercise training pregnancy in women engaged in regular exercise or
weight loss diet program substance abuse morbid obesity BMI > 42
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| NCT ID: |
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NCT00212303 |
| Primary Contact: |
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Principal Investigator
Kerry J Stewart, EdD
Johns Hopkins School of Medicine
Anita C Bacher, MSN, MPH
Phone: 410-550-5429
Email: abach@jhmi.edu
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| Backup Contact: |
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Email: kpotrek1@jhmi.edu
Kristina Marcus, MS
Phone: 410-550-5429
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| Location Contact: |
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Baltimore, Maryland 21224
United States
Kerry J Stewart, EdD
Phone: 410-550-0870
Email: kstewart@jhmi.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
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