Therapeutic Innovation in Type 2 DIABetes (IT-DIAB)

Not Applicable

• Conditions: Pre-diabetes

• Registration Number: NCT01218061
• Lead Sponsor: Nantes University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-10-07
• Study First Submitted QC: 2010-10-08
• Study First Posted: 2010-10-11
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-14
• Last Update Posted: 2017-06-16
• Primary Completion: 2023-06
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 366

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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	10 years	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

Secondary Outcome Measures

Name	Time	Method
Relation between "working hours and conditions" and metabolic disease	10 years	To evaluate the impact of working hours and conditions on the prevalence of metabolic diseases (pre-diabetes, dyslipidemia...)
Number of patients with high Diabetes Risk Score and pre-diabetes	10 years	To evaluate the interest of the Diabetes Risk Score in identifying subjects with pre-diabetes in the French population
Number of patients with others cardiovascular risk factors	10 years	To evaluate the prevalence of others cardiovascular risk factors associated with pre-diabetes: dyslipidemia, hypertension, metabolic liver disease
HbA1c measurement	10 years	To evaluate the role of HbA1C in screening for pre-diabetes and T2D
Number of patients with pre-diabetes	10 years	To evaluate the prevalence of pre-diabetes in the region of Nantes

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France