Therapeutic Innovation in Type 2 DIABetes (IT-DIAB)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01218061
First received: October 7, 2010
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Pre-diabetes
Other: Pre-diabetes screening

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: IT-DIAB (Therapeutic Innovation in Type 2 Diabetes) : Prospective Follow-up of a Cohort of Patients With Pre-diabetes Over 5 Years

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • 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 [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Number of patients with pre-diabetes [ Designated as safety issue: No ]
    To evaluate the prevalence of pre-diabetes in the region of Nantes

  • HbA1c measurement [ Designated as safety issue: No ]
    To evaluate the role of HbA1C in screening for pre-diabetes and T2D

  • 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 [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    To evaluate the impact of working hours and conditions on the prevalence of metabolic diseases (pre-diabetes, dyslipidemia…)


Enrollment: 366
Study Start Date: June 2010
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Pre-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 5 years annual follow-up (V1, V2, V3, V4, V5) with blood sample (fasting glycemia + HbA1C + lipids profile + creatinemia + liver enzymes + serum bank) Making a total of 6 visits (V0-V5) with 6 blood samples.
  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 ≥ 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01218061

Locations
France
Nantes University Hospital
Nantes, France
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Bertrand Cariou, Pr University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01218061     History of Changes
Other Study ID Numbers: 09/11
Study First Received: October 7, 2010
Last Updated: December 10, 2013
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
Cohort
Diabetes Risk Score

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Intolerance
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia

ClinicalTrials.gov processed this record on April 23, 2014