Screening and Understanding of the Pre-diabetes: DECODIAB

Not Applicable

• Conditions: Pre-diabetes

• Registration Number: NCT01739868
• Lead Sponsor: Nantes University Hospital

Brief Summary

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 the population of patients with pre-diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2012-11-23
• Study First Submitted QC: 2012-11-28
• Study First Posted: 2012-12-04
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-15
• Last Update Posted: 2015-04-16
• Primary Completion: 2018-04
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

• Adult patients (≥18 years)
• Subjects with diabetes risk score ≥ 12 or with impaired fasting glucose: blood glucose ≥ 1.10 g/l and < 1 .26 g/L
• And with impaired fasting glucose : blood glucose ≥ 1.10 g/l and < 1 .26 g/L ; or blood glucose ≥ 1g/l and < 1,1 g/L WITH HbA1C ≥ 6,5%
• Signed informed consent
• Subjects affiliated with an appropriate social security system

Exclusion Criteria

• Fasting glycemia ≥ 1.26 g/l
• Fasting glycemia ≤ 1.10 g/l AND HbA1C < 6,5%
• Fasting glycemia < 1 g/l
• Subjects previously treated with oral anti-diabetic: metformin, glitazones, inhibitors of α-glucosidase, sulfonylurea, repaglinide, inhibitors of DPP-IV.
• 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
• Alcohol abuse (> 30g/j)
• Contra-indication in the realization of the local anesthetic
• 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
To identify new biomarkers	5 years	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 the population of patients with pre-diabetes

Secondary Outcome Measures

Name	Time	Method
Number of patients with high Diabetes Risk Score and pre-diabetes	5 years	To evaluate the interest of the Diabetes Risk Score in identifying subjects with pre-diabetes in the French population
To connect identified biomarkers with the degree of insulinoresistance	5 years	To connect identified biomarkers with the degree of insulinoresistance (HOMA-R) and with β pancreatic function (IOG) in the population of patients with pre-diabetes.
To identify new therapeutic targets	5 years	To identify new therapeutic targets for the prevention of the appearance of the diabetes in the population of patients with pre-diabetes
Number of patients with others cardiovascular risk factors	5 years	To evaluate the prevalence of others cardiovascular risk factors associated with pre-diabetes: dyslipidemia, hypertension, metabolic liver disease

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France