Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT01282060
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.
Study:
NCT01282060
Study Brief:
Protocol Section:
NCT01282060