Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT00133718
Status:
COMPLETED
Last Update Posted:
2017-01-24
First Post:
2005-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A 2 Year Trial of Patients With Type 2 Diabetes Focusing on Cardiovascular Diagnostics and Metabolic Control
Sponsor:
Asker & Baerum Hospital
Organization:
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 (n=135) 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 (n=120) 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 (n=135) 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 (n=120) 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 (i.e 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 (i.e 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:
True
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?: