Screening and Understanding of the Pre-diabetes: DECODIAB

Study Overview
=================
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.

Official Title
-----------------
Screening and Understanding of the Pre-diabetes: DECODIAB

Conditions
-----------------
Pre-diabetes

Intervention / Treatment
-----------------
* Other: Biopsies of muscular and fat tissue


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Biopsies of muscular and fat tissue|3 half days of metabolic exploration including blood sample, urinary taking, OGTT (oral glucose tolerance test), biopsies of muscular and fat tissue: 1 visit the first year (inclusion visit) 1 visit at the end of 5 years of follow-up or in the appearance of type 2 diabetes 1 intermediary visit (in 3 years) or activated by the following conditions: Escalation of the glycemia (increase of 0.1g / l of the glycemia and/or 0.3 % of the HbA1c) Normalization of the glycemia (fasting blood glucose < 1 g/l)|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify new biomarkers | 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 | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify new therapeutic targets | To identify new therapeutic targets for the prevention of the appearance of the diabetes in the population of patients with pre-diabetes | 5 years | 
| To connect identified biomarkers with the degree of insulinoresistance | 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. | 5 years | 
| Number of patients with high Diabetes Risk Score and pre-diabetes | To evaluate the interest of the Diabetes Risk Score in identifying subjects with pre-diabetes in the French population | 5 years | 
| Number of patients with others cardiovascular risk factors | To evaluate the prevalence of others cardiovascular risk factors associated with pre-diabetes: dyslipidemia, hypertension, metabolic liver disease | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pre-diabetes, Type 2 diabetes, Biomarkers, Diabetes risk score