Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133718
Status:
COMPLETED
Last Update Posted:
2017-01-24
First Post:
2005-08-23
Brief Title:
A 2 Year Trial of Patients With Type 2 Diabetes Focusing on Cardiovascular Diagnostics and Metabolic Control
Sponsor:
Asker Baerum Hospital
Organization:
Asker Baerum Hospital
Study Overview
Official Title:
Asker and Baerum Cardiovascular Diabetes Study
Status:
COMPLETED
Status Verified Date:
2017-01
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:
None
Brief Summary:
The purposes of this study are
to investigate the extent of cardiovascular complications in a representative cohort n135 of adult patients with type 2 diabetes
to examine if modern non-invasive assessment can replace invasive assessment
to determine the effects of a 6 month lifestyle interventional program on weight glycemic control and lipids in 60 patients
to determine the effect of a 2-year prospective randomised multi-interventional program n120 on cardiovascular risk anthropometric measures and glycometabolic control and
to investigate inflammatory markers in this setting
to investigate the extent of cardiovascular complications in a representative cohort n135 of adult patients with type 2 diabetes
to examine if modern non-invasive assessment can replace invasive assessment
to determine the effects of a 6 month lifestyle interventional program on weight glycemic control and lipids in 60 patients
to determine the effect of a 2-year prospective randomised multi-interventional program n120 on cardiovascular risk anthropometric measures and glycometabolic control and
to investigate inflammatory markers in this setting
Detailed Description:
As cardiovascular disease often is silent in type 2 diabetic patients ways of detecting this early is of potential benefit as is probably an aggressive treatment regimen trying to achieve goals for factors such as blood pressure glycemic control lipids smoking physical activity and weight
This study compares traditional non-invasive tests such as stress-ecg modern non-invasive tests such as holter-analysis modern ECG analysis stress-ecco cardiography and tissue Doppler against the gold standard today for assessing coronary artery disease coronary angiography in patients with type 2 diabetes and at least one cv-risk factor ie smoking premature familial coronary artery disease CAD hypertension irrespective of symptoms or signs of CAD
The participants are included in a randomized-control trial for 2 years where one arm receives standard treatment and one receives treatment after a multi-interventional program
End-points include glycemic control lipid control weight control blood pressure control and effects on inflammatory parameters
This study compares traditional non-invasive tests such as stress-ecg modern non-invasive tests such as holter-analysis modern ECG analysis stress-ecco cardiography and tissue Doppler against the gold standard today for assessing coronary artery disease coronary angiography in patients with type 2 diabetes and at least one cv-risk factor ie smoking premature familial coronary artery disease CAD hypertension irrespective of symptoms or signs of CAD
The participants are included in a randomized-control trial for 2 years where one arm receives standard treatment and one receives treatment after a multi-interventional program
End-points include glycemic control lipid control weight control blood pressure control and effects on inflammatory parameters
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None