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

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

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.

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.

Inclusion Criteria:

• Previous history (within 2 months prior to enrollment visit) of fasting blood glucose ≥ 1,10 g/l and < 1,26 g/l OR fasting blood glucose ≥ 1 g/l and < 1,10 g/l with HbA1c ≥ 6,5%.

Exclusion Criteria:

• Fasting glycemia ≥ 1.26 g/l
• History of treatment with oral antidiabetics
• History of treatment with insulin, except gestational diabetes
• Subject with any history or presence of significant hematologic (coagulation, thrombopenia, …), hepatic, renal, or psychiatric disorders
• Subject unable to follow the study during the 5 years of follow-up
• Subject in exclusion period of a previous study or simultaneously participating to any other clinical trial on metabolism