Overview

This trial is active, not recruiting.

Condition pre-diabetes
Treatment pre-diabetes screening
Sponsor Nantes University Hospital
Start date June 2010
End date June 2018
Trial size 366 participants
Trial identifier NCT01218061, 09/11

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Number of patients with pre-diabetes
time frame:
HbA1c measurement
time frame:
Number of patients with high Diabetes Risk Score and pre-diabetes
time frame:
Number of patients with others cardiovascular risk factors
time frame:
Relation between "working hours and conditions" and metabolic disease
time frame:

Eligibility Criteria

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Nantes University Hospital.