Screening and Understanding of the Pre-diabetes: DECODIAB

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2018

Interventions

  • 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)

Clinical Trial Outcome Measures

Primary Measures

  • To identify new biomarkers
    • Time Frame: 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 Measures

  • To identify new therapeutic targets
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 5 years
    • To evaluate the prevalence of others cardiovascular risk factors associated with pre-diabetes: dyslipidemia, hypertension, metabolic liver disease

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nantes University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bertrand CARIOU, Pr, Principal Investigator, Nantes University Hospital

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