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

Nantes University Hospital (NUH)

Status

Completed

Conditions

Prediabetes

Treatments

Other: Prediabetes screening and prospective follow-up over 5 years

Study type

Interventional

Funder types

Other

Identifiers

NCT01432509

RC12_0385

ID-RCB Number : 2011-A00565-36 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

207 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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