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:
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
  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:

Enrollment: 986
Study Start Date: March 2009
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

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 July 23, 2014