Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-27 @ 10:59 PM
Study NCT ID:
NCT01282060
Status:
UNKNOWN
Last Update Posted:
2017-01-10
First Post:
2011-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between Glycaemic Control and Morbi/Mortality After 5 Years of Follow-up in Type 2 Diabetic Patients
Sponsor:
Association Pour la Recherche en Diabetologie et en Geriatrie
Organization:
Study Overview
Official Title:
Association Between Glycaemic Control and Morbi/Mortality After 5 Years of Follow-up in Type 2 Diabetic Patients
Status:
UNKNOWN
Status Verified Date:
2017-01
Last Known Status:
ACTIVE_NOT_RECRUITING
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 purpose of this study is to asses the link between glycaemic balance (summarised by HBA1C LEVEL) and specific causes of death.
Detailed Description:
The GERODIAB study is the first prospective, longitudinal follow-up cohort study, the main aim of which is to assess the link between glycaemic balance (evaluated on the basis of HbA1c levels) and total mortality at 5 years in diabetic patients aged 70 and over, and suffering from type 2 diabetes. An extension to 10 years is considered given the innovative features of this cohort follow-up procedure.
The secondary endpoints are as follows:
* To assess the link between glycaemic balance and the mortality rate with specific causes.
* To assess the link between glycaemic balance and the onset of or change in diabetes-related complications: cardiovascular diseases, change in renal function, diabetic retinopathy, peripheral neuropathy, perforating ulcer of the foot and acute metabolic complications.
* To assess the link between glycaemic balance and nutritional status, the onset of or changes in cognitive disorders and a loss of autonomy.
* To specify the role of other cardiovascular risk factors combined with glycaemic balance, in mortality, diabetes-related complications, cognitive disorders and loss of autonomy.
The secondary endpoints are as follows:
* To assess the link between glycaemic balance and the mortality rate with specific causes.
* To assess the link between glycaemic balance and the onset of or change in diabetes-related complications: cardiovascular diseases, change in renal function, diabetic retinopathy, peripheral neuropathy, perforating ulcer of the foot and acute metabolic complications.
* To assess the link between glycaemic balance and nutritional status, the onset of or changes in cognitive disorders and a loss of autonomy.
* To specify the role of other cardiovascular risk factors combined with glycaemic balance, in mortality, diabetes-related complications, cognitive disorders and loss of autonomy.
Study Oversight
Has Oversight DMC:
True
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?: