Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00212303
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
2005-09-13
Brief Title:
Exercise Training in Type 2 Diabetes and Hypertension
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
Exercise Training in Type 2 Diabetes and Hypertension
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SHAPE2
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DK62368 | None | None | None |