Therapeutic Innovation in Type 2 DIABetes (IT-DIAB) (IT-DIAB)
Primary Purpose
Pre-diabetes
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pre-diabetes screening
Sponsored by
About this trial
This is an interventional diagnostic trial for Pre-diabetes focused on measuring Pre-diabetes, Type 2 diabetes, Biomarkers, Cohort, Diabetes Risk Score
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
Sites / Locations
- Nantes University Hospital
Outcomes
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
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
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…)
Full Information
NCT ID
NCT01218061
First Posted
October 7, 2010
Last Updated
June 14, 2017
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01218061
Brief Title
Therapeutic Innovation in Type 2 DIABetes (IT-DIAB)
Acronym
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
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-diabetes
Keywords
Pre-diabetes, Type 2 diabetes, Biomarkers, Cohort, Diabetes Risk Score
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
366 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Pre-diabetes screening
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Number of patients with pre-diabetes
Description
To evaluate the prevalence of pre-diabetes in the region of Nantes
Time Frame
10 years
Title
HbA1c measurement
Description
To evaluate the role of HbA1C in screening for pre-diabetes and T2D
Time Frame
10 years
Title
Number of patients with high Diabetes Risk Score and pre-diabetes
Description
To evaluate the interest of the Diabetes Risk Score in identifying subjects with pre-diabetes in the French population
Time Frame
10 years
Title
Number of patients with others cardiovascular risk factors
Description
To evaluate the prevalence of others cardiovascular risk factors associated with pre-diabetes: dyslipidemia, hypertension, metabolic liver disease
Time Frame
10 years
Title
Relation between "working hours and conditions" and metabolic disease
Description
To evaluate the impact of working hours and conditions on the prevalence of metabolic diseases (pre-diabetes, dyslipidemia…)
Time Frame
10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertrand Cariou, Pr
Organizational Affiliation
University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nantes University Hospital
City
Nantes
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
35130909
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.
Results Reference
derived
PubMed Identifier
31785259
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.
Results Reference
derived
PubMed Identifier
31465427
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.
Results Reference
derived
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Therapeutic Innovation in Type 2 DIABetes (IT-DIAB)
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