Association Between Glycaemic Control and Morbi/Mortality After 5 Years of Follow-up in Type 2 Diabetic Patients

• Conditions: Type 2 Diabetes

• Registration Number: NCT01282060
• Lead Sponsor: Association Pour la Recherche en Diabetologie et en Geriatrie

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 Timeline

• Study Start: 2009-03
• Study First Submitted: 2011-01-21
• Study First Submitted QC: 2011-01-21
• Study First Posted: 2011-01-24
• Primary Completion: 2016-04
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-09
• Last Update Posted: 2017-01-10
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 986

Inclusion Criteria

• Patient with type 2 diabetes, aged 70 and over,
• Patient having received medicinal or non-medicinal treatment (in the case of diabetics treated with insulin, the length of time between diagnosis of diabetes and the onset of insulin therapy will be at least 2 years),
• Diabetes diagnosed for at least one year,
• Patient with autonomy defined by a score greater than or equal to 3/6 on the ADL scale,
• Patient who can be monitored during hospital or private consultations over the next 10 years,
• Patient who did not refuse to take part in the study after receiving information on the study (Patient Information Leaflet), Patients are monitored in the hospital or private sector throughout France.

Exclusion Criteria

• Patient with type 1 diabetes,
• Patient with secondary diabetes (mainly corticosteroid-induced),
• Patient with a loss of autonomy defined by a score of less than 3/6 on the ADL scale,
• Patient who cannot be monitored in the months or years to come,
• Patient in an acute situation (transient exclusion criterion),
• Patient expressing their refusal to participate in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Link between HbA1c level and the overall mortality rate at 5 years.	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.

Secondary Outcome Measures

Name	Time	Method
Link between HbA1c level and the onset of or changes in cognitive disorders.	5 years	To assess the link between glycaemic balance and the onset of or changes in cognitive disorders.
Role of other cardiovascular risk factors	5 years	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.
Link between HbA1c level and the onset of or changes in diabetes-related complications	5 years	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).
Link between HbA1c level and specific causes of death.	5 years	To assess the link between glycaemic balance (summarised by HbA1c level) and specific causes of death.
Link between HbA1c level and nutritional status.	5 years	To assess the link between glycaemic balance and nutritional status.
Link between HbA1c level and loss of autonomy.	5 years	To assess the link between glycaemic balance and loss of autonomy.