Pre-diabetesIT-DIABNCT01218061
Therapeutic Innovation in Type 2 DIABetes (IT-DIAB)
A study testing Pre-diabetes screening in people with Pre-diabetes, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pre-diabetes
- What is being tested?
- Pre-diabetes screening
- Type of treatment
- Pill or oral medicine
- How many people
- 366 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2010to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IT-DIAB (Therapeutic Innovation in Type 2 Diabetes) : Prospective Follow-up of a Cohort of Patients With Pre-diabetes Over 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.
- Conditions
- Pre-diabetes
- Being tested
- Pre-diabetes screening
- Keywords
- Pre-diabetes, Type 2 diabetes, Biomarkers, Cohort, Diabetes Risk Score
- Medical subject headings
- Glucose Intolerance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-diabetes screeningOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 years
Secondary outcomes (5)
Number of patients with pre-diabetes
To evaluate the prevalence of pre-diabetes in the region of Nantes
Measured: 10 years
HbA1c measurement
To evaluate the role of HbA1C in screening for pre-diabetes and T2D
Measured: 10 years
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
Measured: 10 years
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
Measured: 10 years
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…)
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pre-diabetesStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertrand Cariou, Pr, Principal investigator, University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01218061
- Sponsor's protocol ID
- PROG/09/11
- Acronym
- IT-DIAB
- Status last verified
- Jun 2017
- First submitted
- 7 Oct 2010
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 40192447Croyal 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.
PubMed 35130909Chavez-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.
PubMed 31785259Wargny 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.
PubMed 31465427
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IT-DIAB (Therapeutic Innovation in Type 2 Diabetes) : Prospective Follow-up of a Cohort of Patients With Pre-diabetes Over 10 Years
- ClinicalTrials.gov ID
- NCT01218061
- Acronym / sponsor ID
- IT-DIAB / PROG/09/11
- Conditions
- Pre-diabetes
- Keywords
- Pre-diabetes, Type 2 diabetes, Biomarkers, Cohort, Diabetes Risk Score
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 366 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jun 2010 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 11 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-diabetes screeningThe 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. | Other | – |
Primary outcome
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
5 secondary outcomes
Number of patients with pre-diabetes
Time frame: 10 years
HbA1c measurement
Time frame: 10 years
Number of patients with high Diabetes Risk Score and pre-diabetes
Time frame: 10 years
Number of patients with others cardiovascular risk factors
Time frame: 10 years
Relation between "working hours and conditions" and metabolic disease
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Derived from this study: PubMed 40192447Rodrigues 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.
- Derived from this study: PubMed 35130909Croyal 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.
- Derived from this study: PubMed 31785259Chavez-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.
- Derived from this study: PubMed 31465427Wargny 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bertrand Cariou, Pr principal investigator
University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-diabetes screening in people with Pre-diabetes, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01218061, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2017.