Pre-diabetes
Conditions
Keywords
Pre-diabetes, Type 2 diabetes, Biomarkers, Cohort, Diabetes Risk Score
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.
Interventions
OTHERPre-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.
Sponsors
Nantes University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with pre-diabetes | 10 years | To evaluate the prevalence of pre-diabetes in the region of Nantes |
| HbA1c measurement | 10 years | To evaluate the role of HbA1C in screening for pre-diabetes and T2D |
| 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 |
| 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…) |
Countries
France
Outcome results
None listed