Trial record 8 of 9685 for: diabetes

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Therapeutic Innovation in Type 2 DIABetes (IT-DIAB)

This study is currently recruiting participants.

Verified October 2010 by Nantes University Hospital

Sponsor:

Information provided by:

Nantes University Hospital

ClinicalTrials.gov Identifier:

NCT01218061

First received: October 7, 2010

Last updated: October 8, 2010

Last verified: October 2010

History of Changes

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 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:

MedlinePlus related topics: Diabetes Diabetes Type 2 Pre-diabetes

U.S. FDA Resources

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: 7 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…)

Estimated Enrollment:	550
Study Start Date:	June 2010
Estimated Study Completion Date:	June 2017
Estimated Primary Completion Date:	June 2017 (Final data collection date for primary outcome measure)

Intervention Details:

diabetes

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01218061

Contacts

Contact: Bertrand Cariou, Pr

02 53 48 27 10

bertrand.cariou@univ-nantes.fr

Locations

France
Nantes University Hospital	Recruiting
Nantes, France
Contact: Bertrand Cariou, Pr 02 53 48 27 10 bertrand.cariou@univ-nantes.fr

Sponsors and Collaborators

Nantes University Hospital

Investigators

Principal Investigator:

Bertrand Cariou, Pr

University Hospital

More Information

No publications provided

Responsible Party:	Anne OMNES, University Hospital of Nantes
ClinicalTrials.gov Identifier:	NCT01218061 History of Changes
Other Study ID Numbers:	09/11
Study First Received:	October 7, 2010
Last Updated:	October 8, 2010
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 May 23, 2013

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