Clinical trial NCT01218061: Therapeutic Innovation in Type 2 DIABetes (IT-DIAB)
Official title: IT-DIAB (Therapeutic Innovation in Type 2 Diabetes) : Prospective Follow-up of a Cohort of Patients With Pre-diabetes Over 10 Years
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pre-diabetes
Keywords: Pre-diabetes
Type 2 diabetes
Biomarkers
Cohort
Diabetes Risk Score
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2010-10-11
Enrollment: 366
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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)
* Patient's opposition
* Subject unable to follow the study during the 5 years of follow-up
* Subject exclusion period in a previous study

Primary outcomes:
measure: 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
timeFrame: 10 years
Secondary outcomes:
measure: Number of patients with pre-diabetes
timeFrame: 10 years
measure: HbA1c measurement
timeFrame: 10 years
measure: Number of patients with high Diabetes Risk Score and pre-diabetes
timeFrame: 10 years
measure: Number of patients with others cardiovascular risk factors
timeFrame: 10 years
measure: Relation between "working hours and conditions" and metabolic disease
timeFrame: 10 years
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: University Hospital
name: Bertrand Cariou, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Croyal M, Wargny M, Chemello K, Chevalier C, Blanchard V, Bigot-Corbel E, Lambert G, Le May C, Hadjadj S, Cariou B. Plasma apolipoprotein concentrations and incident diabetes in subjects with prediabetes. Cardiovasc Diabetol. 2022 Feb 7;21(1):21. doi: 10.1186/s12933-022-01452-5.
citation: Chavez-Talavera O, Wargny M, Pichelin M, Descat A, Vallez E, Kouach M, Bigot-Corbel E, Joliveau M, Goossens JF, Le May C, Hadjadj S, Hanf R, Tailleux A, Staels B, Cariou B. Bile acids associate with glucose metabolism, but do not predict conversion from impaired fasting glucose to diabetes. Metabolism. 2020 Feb;103:154042. doi: 10.1016/j.metabol.2019.154042. Epub 2019 Nov 27.
citation: Wargny M, Smati S, Pichelin M, Bigot-Corbel E, Authier C, Dierry V, Zair Y, Jacquin V, Hadjadj S, Boursier J, Cariou B. Fatty liver index is a strong predictor of changes in glycemic status in people with prediabetes: The IT-DIAB study. PLoS One. 2019 Aug 29;14(8):e0221524. doi: 10.1371/journal.pone.0221524. eCollection 2019.