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

• ClinicalTrials.gov Identifier: NCT01218061
• Recruitment Status: Unknown
• First Posted: October 11, 2010
• Last Update Posted: June 16, 2017
• Sponsor: Nantes University Hospital
• Information provided by (Responsible Party): Nantes University Hospital

Tracking Information

• First Submitted Date: October 7, 2010
• First Posted Date: October 11, 2010
• Last Update Posted Date: June 16, 2017
• Actual Study Start Date: June 2010
• Estimated Primary Completion Date: June 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 14, 2017)

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

Original Primary Outcome Measures (submitted: October 8, 2010)

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 ]

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

Current Secondary Outcome Measures (submitted: June 14, 2017)

• Number of patients with pre-diabetes [ Time Frame: 10 years ]
  To evaluate the prevalence of pre-diabetes in the region of Nantes
• HbA1c measurement [ Time Frame: 10 years ]
  To evaluate the role of HbA1C in screening for pre-diabetes and T2D
• 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
• 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
• 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…)

Original Secondary Outcome Measures (submitted: October 8, 2010)

• Number of patients with pre-diabetes
  To evaluate the prevalence of pre-diabetes in the region of Nantes
• HbA1c measurement
  To evaluate the role of HbA1C in screening for pre-diabetes and T2D
• Number of patients with high Diabetes Risk Score and pre-diabetes
  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
  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
  To evaluate the impact of working hours and conditions on the prevalence of metabolic diseases (pre-diabetes, dyslipidemia…)

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Pre-diabetes

Intervention

Other: 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.

• Study Arms: Not Provided

Publications *

• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: November 6, 2013): 366
• Original Estimated Enrollment (submitted: October 8, 2010): 550
• Estimated Study Completion Date: June 2023
• Estimated Primary Completion Date: June 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01218061
• Other Study ID Numbers: PROG/09/11
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Nantes University Hospital
• Original Responsible Party: Anne OMNES, University Hospital of Nantes
• Current Study Sponsor: Nantes University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Bertrand Cariou, Pr; University Hospital

• PRS Account: Nantes University Hospital
• Verification Date: June 2017