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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:
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: August 25, 2016
Last verified: August 2016
  Purpose
The purpose of this study is to asses the link between glycaemic balance (summarised by HBA1C LEVEL) and specific causes of death.

Condition
Type 2 Diabetes

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

Further study details as provided by Association Pour la Recherche en Diabetologie et en Geriatrie:

Enrollment: 986
Study Start Date: March 2009
Estimated Study Completion Date: September 2021
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   70 Years and older   (Senior)
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

Responsible Party: Association Pour la Recherche en Diabetologie et en Geriatrie
ClinicalTrials.gov Identifier: NCT01282060     History of Changes
Other Study ID Numbers: CRO0662-1 
Study First Received: January 21, 2011
Last Updated: August 25, 2016
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
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Association Pour la Recherche en Diabetologie et en Geriatrie:
HBA1C
DIABETES-RELATED COMPLICATIONS
GLYCAEMIC BALANCE

ClinicalTrials.gov processed this record on December 02, 2016