Therapeutic Innovation in Type 2 DIABetes (IT-DIAB)
This trial is active, not recruiting.
|Sponsor||Nantes University Hospital|
|Start date||June 2010|
|End date||June 2018|
|Trial size||366 participants|
|Trial identifier||NCT01218061, 09/11|
The main objective of the study is to follow prospectively a cohort of patients with pre-diabetes 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.
|Intervention model||single group assignment|
The main objective of the study is 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
time frame: 5 years
Number of patients with pre-diabetes
Number of patients with high Diabetes Risk Score and pre-diabetes
Number of patients with others cardiovascular risk factors
Relation between "working hours and conditions" and metabolic disease
Male or female participants at least 18 years old.
Inclusion Criteria: - Adult patients (≥18 years) - Subjects with diabetes risk score ≥ 15 - Subjects with impaired fasting glucose: blood glucose ≥ 1.10 g/l and < 1 .26 g/L - Subjects affiliated with an appropriate social security system Exclusion Criteria: - Fasting glycemia ≥ 1.26 g/l - Fasting glycemia ≤ 1.10 g/l - Subjects previously treated with oral anti-diabetic: metformin, glitazones, inhibitors of α-glucosidase, sulfonylurea, repaglinide, inhibitors of DPP-IV, GLP-1 R agonists. - Subjects previously treated with insulin, except gestational diabetes - Severe coagulation disorders - Thrombocytopenia < 100 000/mm 3 - Severe psychiatric disorders - Severe renal insufficiency (creatinine clearance < 30 ml/min) - Severe hepatic insufficiency (TP < 50%) - Alcohol abuse (> 30g/j) - Patient's opposition - Subject unable to follow the study during the 5 years of follow-up - Subject exclusion period in a previous study
|Official title||IT-DIAB (Therapeutic Innovation in Type 2 Diabetes) : Prospective Follow-up of a Cohort of Patients With Pre-diabetes Over 5 Years|
|Principal investigator||Bertrand Cariou, Pr|
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