Trial record 19 of 696 for:    prediabetes

Screening and Understanding of the Pre-diabetes: DECODIAB

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014