Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
366 participants
INTERVENTIONAL
2010-06-30
2023-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 ≤ 1.10 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
18 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Bertrand Cariou, Pr
Role: PRINCIPAL_INVESTIGATOR
University Hospital
Locations
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Nantes University Hospital
Nantes, , France
Countries
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References
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Rodrigues Oliveira A, Chevalier C, Wargny M, Pakulska V, Caradeuc C, Cloteau C, Letertre MPM, Giraud N, Bertho G, Bigot-Corbel E, Carpentier M, Nouadje G, Coute Y, Le May C, Cariou B, Hadjadj S, Croyal M. Methylglyoxal-Induced Glycation of Plasma Albumin: From Biomarker Discovery to Clinical Use for Prediction of New-Onset Diabetes in Individuals with Prediabetes. Clin Chem. 2025 Apr 7:hvaf035. doi: 10.1093/clinchem/hvaf035. Online ahead of print.
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.
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.
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.
Other Identifiers
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PROG/09/11
Identifier Type: -
Identifier Source: org_study_id
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