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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01282060
• Other study ID #: CRO0662-1
• Status: Active, not recruiting
• Phase: N/A
• First received: January 21, 2011
• Last updated: January 9, 2017
• Start date: March 2009
• Est. completion date: September 2021

Study information

• Verified date: January 2017
• Source: Association Pour la Recherche en Diabetologie et en Geriatrie
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Conseil National de l'Ordre des MédecinsFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to asses the link between glycaemic balance (summarised by HBA1C LEVEL) and specific causes of death.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 986
• Est. completion date: September 2021
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Type 2 Diabetes

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Association Pour la Recherche en Diabetologie et en Geriatrie	Novo Nordisk A/S, Umanis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Link between HbA1c level and the onset of or changes in diabetes-related complications	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	No
Secondary	Link between HbA1c level and nutritional status.	To assess the link between glycaemic balance and nutritional status.	5 years	No
Secondary	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	No
Secondary	Link between HbA1c level and loss of autonomy.	To assess the link between glycaemic balance and loss of autonomy.	5 years	No
Secondary	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	No