Therapeutic Innovation in Type 2 DIABetes (IT-DIAB)

NCT01218061 | Unknown

• 1 other identifier: PROG/09/11
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-diabetes

Keywords

Pre-diabetes; Type 2 diabetes; Biomarkers; Cohort; Diabetes Risk Score

Outcome Measures

Primary Outcomes (1)

• 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

  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 Outcomes (5)

• Number of patients with pre-diabetes

  10 years

• HbA1c measurement

  10 years

• Number of patients with high Diabetes Risk Score and pre-diabetes

  10 years

• Number of patients with others cardiovascular risk factors

  10 years

• Relation between "working hours and conditions" and metabolic disease

  10 years

Interventions

Pre-diabetes screening OTHER

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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, France

Location

Related Publications (4)

• 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 Jun 3;71(6):688-699. doi: 10.1093/clinchem/hvaf035.

  PMID: 40192447 DERIVED

• 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.

  PMID: 35130909 DERIVED

• 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.

  PMID: 31785259 DERIVED

• 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.

  PMID: 31465427 DERIVED

MeSH Terms

Conditions

Glucose Intolerance; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Bertrand Cariou, Pr

  University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2010
• First Posted: October 11, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 16, 2017

Record last verified: 2017-06

Locations

FR (1)