Clinical Trial: Prospective Follow-up of a Cohort of Pre-diabetics in the North of France (DiabeNord)

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: DiabeNord: A 5-year Prospective Follow-up Cohort Study in Pre-diabetic Subjects for the Identification of New Biomarkers

Brief Summary: The purpose of this study is to identify in prediabetic subjects, physiopathological changes involved in the evolution to type 2 diabetes mellitus and to identify new biomarkers of type 2 diabetes risk in this population.

Detailed Summary: Type 2 diabetes (T2D) is a real public health issue, with an exponential incidence. Before its diagnosis, several physiopathological changes are already taking place, such as insulin resistance of target tissues and the progressive inability of pancreatic beta cells to produce insulin. The objective of this study is a better understanding of the prediabetic stage and mechanisms involved in the possible development of T2D, by way of a five-year follow-up cohort study in 207 prediabetic subjects.
Sponsor: Nantes University Hospital

Current Primary Outcome: Type 2 Diabetes occurrence [ Time Frame: 5 years (or less if occurrence of the condition) ]

To understand the pathophysiological mechanisms involved in switching from pre-diabetes to type 2 diabetes and to identify new biomarkers of type 2 diabetes risk in this population


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Biomarkers [ Time Frame: 7 to 10 years ]
    To highlight biomarkers of prediabetes, type 2 diabetes and cardiometabolic diseases, through genomics, proteomics and transcriptomics analyses performed on a biological sample collection.
  • Number of patients with pre-diabetes in North of France [ Time Frame: 5 years ]
    To estimate the prevalence of prediabetes in the region Nord-Pas-de-Calais (France)
  • HbA1c measurement [ Time Frame: 5 years ]
    To evaluate the role of HbA1c in screening for pre-diabetes and type 2 diabetes
  • Diabetes Risk Score [ Time Frame: 5 years ]
    To assess the interest of Diabetes Risk Score (questionnaire used to evaluate a clinical risk) in identifying subjects at risk of type 2 diabetes
  • Others cardiovascular risk factors [ Time Frame: 5 years ]
    To measure the prevalence of other cardiovascular risk factors observed along with prediabetes: dyslipidemia, metabolic hepatopathy


Original Secondary Outcome: Same as current

Information By: Nantes University Hospital

Dates:
Date Received: September 9, 2011
Date Started: September 2011
Date Completion: December 2017
Last Updated: June 23, 2016
Last Verified: June 2016