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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Novo Nordisk A/S
Umanis
Information provided by (Responsible Party):
Association Pour la Recherche en Diabetologie et en Geriatrie
ClinicalTrials.gov Identifier:
NCT01282060
First received: January 21, 2011
Last updated: January 9, 2017
Last verified: January 2017
January 21, 2011
January 9, 2017
March 2009
April 2016   (Final data collection date for primary outcome measure)
Link between HbA1c level and the overall mortality rate at 5 years. [ Time Frame: 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.
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Complete list of historical versions of study NCT01282060 on ClinicalTrials.gov Archive Site
  • Link between HbA1c level and specific causes of death. [ Time Frame: 5 years ]
    To assess the link between glycaemic balance (summarised by HbA1c level) and specific causes of death.
  • Link between HbA1c level and the onset of or changes in diabetes-related complications [ Time Frame: 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 nutritional status. [ Time Frame: 5 years ]
    To assess the link between glycaemic balance and nutritional status.
  • Link between HbA1c level and the onset of or changes in cognitive disorders. [ Time Frame: 5 years ]
    To assess the link between glycaemic balance and the onset of or changes in cognitive disorders.
  • Link between HbA1c level and loss of autonomy. [ Time Frame: 5 years ]
    To assess the link between glycaemic balance and loss of autonomy.
  • Role of other cardiovascular risk factors [ Time Frame: 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.
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Association Between Glycaemic Control and Morbi/Mortality After 5 Years of Follow-up in Type 2 Diabetic Patients
Association Between Glycaemic Control and Morbi/Mortality After 5 Years of Follow-up in Type 2 Diabetic Patients
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:

  • 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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
  • Patients suffering from type 2 diabetes and aged 70 and over.
  • Having received medicinal or non-medicinal therapy (in the case of diabetics treated with insulin, the lengh of time between diagnosis of diabtees and the introduction of insulin therapy is at least 6 months).
  • Suffering from type 2 diabetes at least one year.
  • With autonomy defined by a score greater than or equal to 3/6 on the ADL scale and able of being followed-up during hospital or private consultations over the next 5 years.
  • Patients who did not refuse to participate in the study after receiving information on the study (Patient Information Leaflet).

The patient are monitored in the hospital or private sector throughout Metropolitan France.

Type 2 Diabetes
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
986
September 2021
April 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
70 Years and older   (Senior)
No
Contact information is only displayed when the study is recruiting subjects
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NCT01282060
CRO0662-1
Yes
Not Provided
No
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Association Pour la Recherche en Diabetologie et en Geriatrie
Association Pour la Recherche en Diabetologie et en Geriatrie
  • Novo Nordisk A/S
  • Umanis
Not Provided
Association Pour la Recherche en Diabetologie et en Geriatrie
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP