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Exercise Training in Type 2 Diabetes and Hypertension (SHAPE2)
This study is currently recruiting participants.
Study NCT00212303   Information provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First Received: September 13, 2005   Last Updated: September 29, 2009   History of Changes

September 13, 2005
September 29, 2009
May 2004
December 2010   (final data collection date for primary outcome measure)
Blood pressure at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Blood pressure at 6 months
Complete list of historical versions of study NCT00212303 on ClinicalTrials.gov Archive Site
  • Cardiac and peripheral structure and function at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Fitness and body composition at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Cardiac and diabetes risk factors at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Systemic inflammation at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Cardiac and peripheral structure and function at 6 months
  • Fitness and body composition at 6 months
  • Cardiac and diabetes risk factors at 6 months
  • Systemic inflammation at 6 months
 
Exercise Training in Type 2 Diabetes and Hypertension
Exercise Training in Type 2 Diabetes and Hypertension

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.

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.

Phase IV
Interventional
Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
  • Type 2 Diabetes
  • Hypertension
  • Behavioral: Exercise training for 6 months
  • Behavioral: Exercise training
  • Experimental: Exercise training, 3 times per week, for 6 months.
  • No Intervention: Usual care no active exercise intervention
Bennett WL, Ouyang P, Wu AW, Barone BB, Stewart KJ. Fatness and fitness: how do they influence health-related quality of life in type 2 diabetes mellitus? Health Qual Life Outcomes. 2008 Dec 4;6:110.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
120
December 2010
December 2010   (final data collection date for primary outcome measure)

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

Both
40 Years to 65 Years
No
Contact: Anita C Bacher, MSN, MPH 410-550-5429 abach@jhmi.edu
Contact: Kristina Marcus, MS 410-550-5429 kpotrek1@jhmi.edu
United States
 
NCT00212303
Kerry J Stewart, Johns Hopkins University
DK62368, DK62368
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 
Principal Investigator: Kerry J Stewart, EdD Johns Hopkins School of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP