Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00284609
Status:
COMPLETED
Last Update Posted:
2010-03-26
First Post:
2006-01-17
Brief Title:
Rehabilitation of Type 2 Diabetes Patients
Sponsor:
Bispebjerg Hospital
Organization:
Bispebjerg Hospital
Study Overview
Official Title:
The Effect of Rehabilitation of Type 2 Diabetes Mellitus Versus Standard Outpatient Care A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2009-01
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 aim of this study is to investigate the effect of a new rehabilitation program of type 2 diabetes patients in a primary care center versus standard care in the outpatient Hospital Clinic
Detailed Description:
Type 2 diabetes is major and growing health care problem and is associated with premature mortality and increased morbidity At the time of diagnosis half of the patients have cardiovascular renal ophthalmic or neurological disease A recent Danish intervention study found a marked reduction in cardiovascular events and microvascular complications in a group of patients with type 2 diabetes and microalbuminuria using an intensive multifactorial pharmacologic intervention and lifestyle intervention 3 The achieved changes in lifestyle seems however to vanish after a short period Lack of information unawareness of the seriousness of the disease and lack of supervised training and insufficient follow-up may be of importance of the long-term outcome in these patients
A total number of 180 patients with type 2 diabetes will be randomized to the intervention group or to standard care
This study tests an intensive intervention of lifestyle by a newly developed program of rehabilitation compared with routine standards in a randomized controlled design Provided that a significant positive outcome is found the non-pharmacologic treatment of type 2 diabetes could be optimized and inpatient hospitalization due to complications could be avoided
A total number of 180 patients with type 2 diabetes will be randomized to the intervention group or to standard care
This study tests an intensive intervention of lifestyle by a newly developed program of rehabilitation compared with routine standards in a randomized controlled design Provided that a significant positive outcome is found the non-pharmacologic treatment of type 2 diabetes could be optimized and inpatient hospitalization due to complications could be avoided
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 |
|---|---|---|---|
| 2005-41-6000 | None | None | None |
| MPU 39-2005 | None | None | None |