Pre-diabetes
Conditions
Keywords
Pre-diabetes, Type 2 diabetes, Biomarkers, Diabetes risk score
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.
Interventions
OTHERBiopsies 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)
Sponsors
Nantes University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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 ≥ 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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 |
| 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 |
Countries
France
Outcome results
None listed