Association Between Glycaemic Control and Morbi/Mortality After 5 Years of Follow-up in Type 2 Diabetic Patients 70 Years Old and Over : a Cohort Study.
This study is ongoing, but not recruiting participants.
Sponsor:
Association Pour la Recherche en Diabetologie et en Geriatrie
Information provided by:
Association Pour la Recherche en Diabetologie et en Geriatrie
ClinicalTrials.gov Identifier:
NCT01282060
First received: January 21, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
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Purpose
The purpose of this study is to asses the link between glycaemic balance (summarised by HBA1C LEVEL) and specific causes of death.
Condition |
---|
Diabetes Mellitus, Type 2 |
Study Type: | Observational |
Study Design: | Observational Model: Cohort Time Perspective: Prospective |
Official Title: | Association Between Glycaemic Control and Morbi/Mortality After 5 Years of Follow-up in Type 2 Diabetic Patients . |
Resource links provided by NLM:
Further study details as provided by Association Pour la Recherche en Diabetologie et en Geriatrie:
Eligibility
Ages Eligible for Study: | 70 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Study Population
- 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.
Criteria
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.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
Keywords provided by Association Pour la Recherche en Diabetologie et en Geriatrie:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 26, 2012
No publications provided
Responsible Party: | Pr DOUCET jean, GERODIAB |
ClinicalTrials.gov Identifier: | NCT01282060 History of Changes |
Other Study ID Numbers: | CRO0662-1 |
Study First Received: | January 21, 2011 |
Last Updated: | January 21, 2011 |
Health Authority: | France: Conseil National de l'Ordre des Médecins France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé |
Keywords provided by Association Pour la Recherche en Diabetologie et en Geriatrie:
HBA1C DIABETES-RELATED COMPLICATIONS GLYCAEMIC BALANCE |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on September 26, 2012