Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114998
Status:
COMPLETED
Last Update Posted:
2012-08-01
First Post:
2005-06-20
Brief Title:
CV Disease in Adolescents With Type 2 Diabetes
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
CV Disease in Adolescents With Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2012-07
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:
None
Brief Summary:
To study cardiac and vascular structure and function in a population of adolescents with type 2 diabetes mellitus T2DM compared to a similar group with obesity alone and a similar non-obese group
Detailed Description:
BACKGROUND
The prevalence of type 2 diabetes mellitus has increased dramatically in adolescents This appears to be a direct result of the increase in prevalence and severity of obesity in the pediatric population In adults with type 2 diabetes it is well known that the risk for cardiovascular disease CVD is quite high This has led to current clinical recommendation that adults with diabetes be considered equivalent in risk to those adults who already have existing coronary artery disease It is not known if adolescents with type 2 diabetes have an equivalent high level of risk of CVD as the adult population If they do then it would be expected that they would develop clinical CVD in their late 20s or 30s This would have important clinical implications and would suggest the need for very aggressive management of CVD risk factors and diabetes
DESIGN NARRATIVE
The study is a cross-sectional evaluation of cardiac and vascular structure and function in a population of adolescents with type 2 diabetes compared to a group with similar age sex race and BMI with obesity alone and a non obese group with similar age sex and race 300 subjects with type 2 diabetes 300 subjects with obesity and 300 non obese subjects will be studied Assessment of CVD development will be accomplished using novel non invasive imaging methods for subclinical atherosclerosis including echocardiographic measurement of cardiac structure and function ultrasound evaluation of carotid intimal medial thickness and evaluation of endothelial function by brachial artery reactivity The primary hypothesis is that adolescents with type 2 diabetes will have greater abnormality in cardiac and vascular structure and function compared to controls with obesity Subjects with obesity alone will have greater abnormality in cardiac and vascular structure and function compared to controls who are not obese Correlates of cardiac and vascular abnormalities including markers of inflammation adiponectin diet and physical activity will also be evaluated
The prevalence of type 2 diabetes mellitus has increased dramatically in adolescents This appears to be a direct result of the increase in prevalence and severity of obesity in the pediatric population In adults with type 2 diabetes it is well known that the risk for cardiovascular disease CVD is quite high This has led to current clinical recommendation that adults with diabetes be considered equivalent in risk to those adults who already have existing coronary artery disease It is not known if adolescents with type 2 diabetes have an equivalent high level of risk of CVD as the adult population If they do then it would be expected that they would develop clinical CVD in their late 20s or 30s This would have important clinical implications and would suggest the need for very aggressive management of CVD risk factors and diabetes
DESIGN NARRATIVE
The study is a cross-sectional evaluation of cardiac and vascular structure and function in a population of adolescents with type 2 diabetes compared to a group with similar age sex race and BMI with obesity alone and a non obese group with similar age sex and race 300 subjects with type 2 diabetes 300 subjects with obesity and 300 non obese subjects will be studied Assessment of CVD development will be accomplished using novel non invasive imaging methods for subclinical atherosclerosis including echocardiographic measurement of cardiac structure and function ultrasound evaluation of carotid intimal medial thickness and evaluation of endothelial function by brachial artery reactivity The primary hypothesis is that adolescents with type 2 diabetes will have greater abnormality in cardiac and vascular structure and function compared to controls with obesity Subjects with obesity alone will have greater abnormality in cardiac and vascular structure and function compared to controls who are not obese Correlates of cardiac and vascular abnormalities including markers of inflammation adiponectin diet and physical activity will also be evaluated
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 |
|---|---|---|---|
| R01HL076269 | NIH | None | httpsreporternihgovquickSearchR01HL076269 |