NCT01218061

Therapeutic Innovation in Type 2 DIABetes (IT-DIAB)

IT-DIAB (Therapeutic Innovation in Type 2 Diabetes) : Prospective Follow-up of a Cohort of Patients With Pre-diabetes Over 10 Years

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 366 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pre-diabetes

Interventions

Type	Name	Description
OTHER	Pre-diabetes screening	The timing of the study is :- Screening of high metabolic risk patients based on a clinical score : Finnish Diabetes Risk Score ≥ 15- if Diabetes Risk Score ≥ 15 or if history of blood glucose between 1.10 and 1.26 g/l (impaired fasting glucose): measuring fasting glycaemia + HbA1C + lipids profile + creatinemia + liver enzymes- if fasting blood glucose between 1.10 and 1.26 g/l (=V0):\* OGTT (oral glucose tolerance test) to identify subjects with impaired glucose tolerance (optional)\* establishment of a serum bank to identify biomarkers (serum, genomic, proteomic) - to plan for 10 years annual follow-up (V1 to V10) with blood sample (fasting glycemia + HbA1C + lipids profile + creatinemia + liver enzymes + serum bank (not after V5)) Making a total of 11 visits (V0-V10) with 6 blood samples.

Timeline

• Start date: 2010-06-01
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2010-10-11
• Last updated: 2017-06-16

Locations

1 site across 1 country: France