Therapeutic Innovation in Type 2 DIABetes (IT-DIAB)

Study Overview
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Brief Summary
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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.

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

Conditions
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Pre-diabetes

Intervention / Treatment
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* Other: Pre-diabetes screening


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with pre-diabetes | To evaluate the prevalence of pre-diabetes in the region of Nantes | 10 years | 
| HbA1c measurement | To evaluate the role of HbA1C in screening for pre-diabetes and T2D | 10 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 | 10 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 | 10 years | 
| Relation between working hours and conditions and metabolic disease | To evaluate the impact of working hours and conditions on the prevalence of metabolic diseases (pre-diabetes, dyslipidemia…) | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre-diabetes, Type 2 diabetes, Biomarkers, Cohort, Diabetes Risk Score