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Therapeutic Innovation in Type 2 DIABetes (IT-DIAB)

N

Nantes University Hospital (NUH)

Status

Unknown

Conditions

Pre-diabetes

Treatments

Other: Pre-diabetes screening

Study type

Interventional

Funder types

Other

Identifiers

NCT01218061
PROG/09/11

Details and patient eligibility

About

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.

Enrollment

366 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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