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

NCT01282060 | Unknown DMC

• 1 other identifier: CRO0662-1
• Study Type: observational
• Target: 986
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Type 2 Diabetes

Keywords

HBA1C; DIABETES-RELATED COMPLICATIONS; GLYCAEMIC BALANCE

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Link between HbA1c level and specific causes of death.

  5 years

• Link between HbA1c level and the onset of or changes in diabetes-related complications

  5 years

• Link between HbA1c level and nutritional status.

  5 years

• Link between HbA1c level and the onset of or changes in cognitive disorders.

  5 years

• Link between HbA1c level and loss of autonomy.

  5 years

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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 expressing their refusal to participate in the study.

Sponsors & Collaborators

• Association Pour la Recherche en Diabetologie et en Geriatrie: lead
• Novo Nordisk A/S: collaborator
• Umanis: collaborator

Related Publications (3)

• Doucet J, Verny C, Bordier L, Rekik A, Zulfiqar AA, Bezerra CB, Bauduceau B. Evolution in geriatric syndromes and association with survival over 5 years in the GERODIAB cohort of older French diabetic patients. Eur Geriatr Med. 2021 Jun;12(3):619-625. doi: 10.1007/s41999-020-00425-9. Epub 2020 Nov 22.

  PMID: 33225383 DERIVED

• Doucet J, Verny C, Balkau B, Scheen AJ, Bauduceau B. Haemoglobin A1c and 5-year all-cause mortality in French type 2 diabetic patients aged 70 years and older: The GERODIAB observational cohort. Diabetes Metab. 2018 Dec;44(6):465-472. doi: 10.1016/j.diabet.2018.05.003. Epub 2018 May 18.

  PMID: 29859993 DERIVED

• Bauduceau B, Le Floch JP, Halimi S, Verny C, Doucet J; SFD/SFGG Intergroup. Cardiovascular Complications Over 5 Years and Their Association With Survival in the GERODIAB Cohort of Elderly French Patients With Type 2 Diabetes. Diabetes Care. 2018 Jan;41(1):156-162. doi: 10.2337/dc17-1437. Epub 2017 Nov 7.

  PMID: 29113984 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Complications

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2011
• First Posted: January 24, 2011
• Study Start: March 1, 2009
• Primary Completion: April 1, 2016
• Study Completion: September 1, 2021
• Last Updated: January 10, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share