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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
| Umanis | INDUSTRY |
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The purpose of this study is to asses the link between glycaemic balance (summarised by HBA1C LEVEL) and specific causes of death.
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:
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| Measure | Description | Time Frame |
|---|---|---|
| Link between HbA1c level and the overall mortality rate at 5 years. | The primary endpoint is to assess the link between glycaemic balance (assessed on the basis of the HbA1c level) and the overall mortality rate at 5 years for patients of 70 and over suffering from type 2 diabetes. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Link between HbA1c level and specific causes of death. | To assess the link between glycaemic balance (summarised by HbA1c level) and specific causes of death. | 5 years |
| Link between HbA1c level and the onset of or changes in diabetes-related complications |
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Inclusion Criteria:
Exclusion Criteria:
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The patient are monitored in the hospital or private sector throughout Metropolitan France.
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33225383 | Derived | Doucet J, Verny C, Bordier L, Rekik A, Zulfiqar AA, Bezerra CB, Bauduceau B. Evolution in geriatric syndromes and association with survival over 5 years in the GERODIAB cohort of older French diabetic patients. Eur Geriatr Med. 2021 Jun;12(3):619-625. doi: 10.1007/s41999-020-00425-9. Epub 2020 Nov 22. | |
| 29859993 | Derived |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D048909 | Diabetes Complications |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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To assess the link between glycaemic balance (summarised by HbA1c) and the onset of or changes in diabetes-related complications: - cardiovascular diseases (coronary failure, heart failure, cerebrovascular accidents, arteriopathy obliterans of the lower limbs), - change in renal function, diabetic retinopathy, peripheral neuropathy, perforating ulcer of the foot, acute metabolic complications (hypoglycaemia, diabetic ketoacidosis, hyperosmolarity). |
| 5 years |
| Link between HbA1c level and nutritional status. | To assess the link between glycaemic balance and nutritional status. | 5 years |
| Link between HbA1c level and the onset of or changes in cognitive disorders. | To assess the link between glycaemic balance and the onset of or changes in cognitive disorders. | 5 years |
| Link between HbA1c level and loss of autonomy. | To assess the link between glycaemic balance and loss of autonomy. | 5 years |
| Role of other cardiovascular risk factors | To specify the role of other cardiovascular risk factors (primarily, arterial hypertension, dyslipidaemia and obesity) in association with glycaemic balance on the mortality rate, diabetes-related complications, cognitive disorders and loss of autonomy. | 5 years |
| Doucet J, Verny C, Balkau B, Scheen AJ, Bauduceau B. Haemoglobin A1c and 5-year all-cause mortality in French type 2 diabetic patients aged 70 years and older: The GERODIAB observational cohort. Diabetes Metab. 2018 Dec;44(6):465-472. doi: 10.1016/j.diabet.2018.05.003. Epub 2018 May 18. |
| 29113984 | Derived | Bauduceau B, Le Floch JP, Halimi S, Verny C, Doucet J; SFD/SFGG Intergroup. Cardiovascular Complications Over 5 Years and Their Association With Survival in the GERODIAB Cohort of Elderly French Patients With Type 2 Diabetes. Diabetes Care. 2018 Jan;41(1):156-162. doi: 10.2337/dc17-1437. Epub 2017 Nov 7. |
| D004700 | Endocrine System Diseases |