Therapeutic Innovation in Type 2 DIABetes (IT-DIAB) (IT-DIAB)

June 14, 2017 updated by: Nantes University Hospital

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

366

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France
        • Nantes University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with pre-diabetes
Time Frame: 10 years
To evaluate the prevalence of pre-diabetes in the region of Nantes
10 years
HbA1c measurement
Time Frame: 10 years
To evaluate the role of HbA1C in screening for pre-diabetes and T2D
10 years
Number of patients with high Diabetes Risk Score and pre-diabetes
Time Frame: 10 years
To evaluate the interest of the Diabetes Risk Score in identifying subjects with pre-diabetes in the French population
10 years
Number of patients with others cardiovascular risk factors
Time Frame: 10 years
To evaluate the prevalence of others cardiovascular risk factors associated with pre-diabetes: dyslipidemia, hypertension, metabolic liver disease
10 years
Relation between "working hours and conditions" and metabolic disease
Time Frame: 10 years
To evaluate the impact of working hours and conditions on the prevalence of metabolic diseases (pre-diabetes, dyslipidemia…)
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Bertrand Cariou, Pr, University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2010

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

October 7, 2010

First Submitted That Met QC Criteria

October 8, 2010

First Posted (Estimate)

October 11, 2010

Study Record Updates

Last Update Posted (Actual)

June 16, 2017

Last Update Submitted That Met QC Criteria

June 14, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROG/09/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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