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Clinical Trials/NCT01218061
NCT01218061
Unknown
Not Applicable

IT-DIAB (Therapeutic Innovation in Type 2 Diabetes) : Prospective Follow-up of a Cohort of Patients With Pre-diabetes Over 10 Years

Nantes University Hospital1 site in 1 country366 target enrollmentJune 2010
ConditionsPre-diabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pre-diabetes
Sponsor
Nantes University Hospital
Enrollment
366
Locations
1
Primary Endpoint
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
Last Updated
8 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 2010
End Date
June 2023
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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)

Outcomes

Primary Outcomes

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: 10 years

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 Outcomes

  • Relation between "working hours and conditions" and metabolic disease(10 years)
  • Number of patients with high Diabetes Risk Score and pre-diabetes(10 years)
  • Number of patients with others cardiovascular risk factors(10 years)
  • HbA1c measurement(10 years)
  • Number of patients with pre-diabetes(10 years)

Study Sites (1)

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