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Exercise Training in Type 2 Diabetes and Hypertension (SHAPE2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00212303
First Posted: September 21, 2005
Last Update Posted: January 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kerry Stewart, Johns Hopkins University
  Purpose
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.

Condition Intervention Phase
Type 2 Diabetes Hypertension Behavioral: Exercise training for 6 months Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exercise Training in Type 2 Diabetes and Hypertension

Resource links provided by NLM:


Further study details as provided by Kerry Stewart, Johns Hopkins University:

Primary Outcome Measures:
  • Blood pressure at 6 months [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Cardiac and peripheral structure and function at 6 months [ Time Frame: 6 months ]
  • Fitness and body composition at 6 months [ Time Frame: 6 months ]
  • Cardiac and diabetes risk factors at 6 months [ Time Frame: 6 months ]
  • Systemic inflammation at 6 months [ Time Frame: 6 months ]

Enrollment: 115
Study Start Date: May 2004
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise training
Exercise training, 3 times per week, for 6 months.
Behavioral: Exercise training for 6 months
Exercise 3 times/week for 6 months. Exercise consists of aerobic and resistance exercise
No Intervention: Control
Usual care no active exercise intervention

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00212303


Locations
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Kerry J Stewart, EdD Johns Hopkins School of Medicine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kerry Stewart, Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00212303     History of Changes
Other Study ID Numbers: DK62368 (completed)
DK62368
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: January 23, 2013
Last Verified: January 2013

Keywords provided by Kerry Stewart, Johns Hopkins University:
type 2 diabetes
hypertension
exercise training
cardiac, peripheral
body composition
physical fitness
inflammation

Additional relevant MeSH terms:
Diabetes Mellitus
Hypertension
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases