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
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: 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 July 31, 2014