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Therapeutic Innovation in Type 2 DIABetes (IT-DIAB)

NCT01218061 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 366

Last updated 2017-06-16

No results posted yet for this study

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.

Conditions

  • Pre-diabetes

Interventions

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 10 years annual follow-up (V1 to V10) with blood sample (fasting glycemia + HbA1C + lipids profile + creatinemia + liver enzymes + serum bank (not after V5)) Making a total of 11 visits (V0-V10) with 6 blood samples.

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Bertrand Cariou, Pr · University Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2023-06-30
Completion
2023-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01218061 on ClinicalTrials.gov