Text Size

Screening and Understanding of the Pre-diabetes: DECODIAB

This study is currently recruiting participants.
Verified November 2012 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01739868
First received: November 23, 2012
Last updated: November 28, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Pre-diabetes
 Other: Biopsies of muscular and fat tissue

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Official Title: Screening and Understanding of the Pre-diabetes: DECODIAB

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • To identify new biomarkers [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • To identify new therapeutic targets [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To evaluate the prevalence of others cardiovascular risk factors associated with pre-diabetes: dyslipidemia, hypertension, metabolic liver disease


Estimated Enrollment: 110
Study Start Date: April 2011
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01739868

Contacts
Contact: Bertrand CARIOU, Pr 02 53 48 27 10

Locations
France
Nantes University Hospital Recruiting
Nantes, France
Contact: Bertrand CARIOU, Pr     02 53 48 27 10        
Principal Investigator: Bertrand CARIOU, Pr            
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Bertrand CARIOU, Pr Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01739868     History of Changes
Other Study ID Numbers: 09/9-A
Study First Received: November 23, 2012
Last Updated: November 28, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
Pre-diabetes
Type 2 diabetes
Biomarkers
Diabetes risk score

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Intolerance
Prediabetic State
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Hyperglycemia

ClinicalTrials.gov processed this record on May 19, 2013