PrediabetesDiabeNordNCT01432509
Prospective Follow-up of a Cohort of Pre-diabetics in the North of France (DiabeNord)
A study testing Prediabetes screening and prospective follow-up over 5 years in people with Prediabetes, run by Nantes University Hospital at 1 site in France.
Trial summary
The purpose of this study is to identify in prediabetic subjects, physiopathological changes involved in the evolution to type 2 diabetes mellitus 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
- Prediabetes
- What is being tested?
- Prediabetes screening and prospective follow-up over 5 years
- How many people
- 207 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2011to 23 Nov 2017
- 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
- Previous history (within 2 months prior to enrollment visit) of fasting blood glucose ≥ 1,10 g/l and < 1,26 g/l OR fasting blood glucose ≥ 1 g/l and < 1,10 g/l with HbA1c ≥ 6,5%.
Who cannot join
- Fasting glycemia ≥ 1.26 g/l
- History of treatment with oral antidiabetics
- History of treatment with insulin, except gestational diabetes
- Subject with any history or presence of significant hematologic (coagulation, thrombopenia, …), hepatic, renal, or psychiatric disorders
- Subject unable to follow the study during the 5 years of follow-up
- Subject in exclusion period of a previous study or simultaneously participating to any other clinical trial on metabolism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DiabeNord: A 5-year Prospective Follow-up Cohort Study in Pre-diabetic Subjects for the Identification of New Biomarkers
The purpose of this study is to identify in prediabetic subjects, physiopathological changes involved in the evolution to type 2 diabetes mellitus and to identify new biomarkers of type 2 diabetes risk in this population.
Read the detailed description
Type 2 diabetes (T2D) is a real public health issue, with an exponential incidence. Before its diagnosis, several physiopathological changes are already taking place, such as insulin resistance of target tissues and the progressive inability of pancreatic beta cells to produce insulin. The objective of this study is a better understanding of the prediabetic stage and mechanisms involved in the possible development of T2D, by way of a five-year follow-up cohort study in 207 prediabetic subjects.
- Conditions
- Prediabetes
- Being tested
- Prediabetes screening and prospective follow-up over 5 years
- Keywords
- Pre-diabetes, Type 2 diabetes, Biomarkers, Cohort, Diabetes Risk Score, Diabetes Mellitus, Type 2, Glucose Intolerance, Prediabetic State, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Hyperglycemia
- Medical subject headings
- Prediabetic State, Glucose Intolerance, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prediabetes screening and prospective follow-up over 5 yearsOther
The study period per patient is 5 years. The planned schedule of the study is as follows :
- Enrollment at visit V0 of subjects at high metabolic risk, based on a biological value (within the past 2 months) of moderate fasting hyperglycaemia (blood glucose ≥ 1,10 g/l and < 1,26 g/l) or fasting blood glucose ≥ 1 g/l and < 1,10 g/l with HbA1c ≥ 6,5%.
- First biological sample (B0) within 1 month following V0 (measuring fasting blood glucose + glycated hemoglobin HbA1c + lipid profile + creatinemia + liver function; and establishment of a biological sample collection to identify biomarkers).
- Annual follow-up for five years consisting in one blood sample (B1 to B5) measuring the same parameters as V0 + biological sample collection, and questionnaire on major health events or health events related to study procedures.
- End of study phone call
What is being measured
The primary outcome is the main question the study is designed to answer.
Type 2 Diabetes occurrence
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: 5 years (or less if occurrence of the condition)
Secondary outcomes (5)
Biomarkers
To highlight biomarkers of prediabetes, type 2 diabetes and cardiometabolic diseases, through genomics, proteomics and transcriptomics analyses performed on a biological sample collection.
Measured: 7 to 10 years
Number of patients with pre-diabetes in North of France
To estimate the prevalence of prediabetes in the region Nord-Pas-de-Calais (France)
Measured: 5 years
HbA1c measurement
To evaluate the role of HbA1c in screening for pre-diabetes and type 2 diabetes
Measured: 5 years
Diabetes Risk Score
To assess the interest of Diabetes Risk Score (questionnaire used to evaluate a clinical risk) in identifying subjects at risk of type 2 diabetes
Measured: 5 years
Others cardiovascular risk factors
To measure the prevalence of other cardiovascular risk factors observed along with prediabetes: dyslipidemia, metabolic hepatopathy
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2011 (estimated)
- Study startSep 2011
- Primary completion23 Nov 2017
- Study completion23 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PrediabetesStudies 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
- 207 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 of Nantes, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01432509
- Sponsor's protocol ID
- RC12_0385
- Other IDs
- ID-RCB Number : 2011-A00565-36
- Acronym
- DiabeNord
- Status last verified
- Apr 2018
- First submitted
- 9 Sep 2011
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 35130909Wargny 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 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DiabeNord: A 5-year Prospective Follow-up Cohort Study in Pre-diabetic Subjects for the Identification of New Biomarkers
- ClinicalTrials.gov ID
- NCT01432509
- Acronym / sponsor ID
- DiabeNord / RC12_0385
- Conditions
- Prediabetes
- Keywords
- Pre-diabetes, Type 2 diabetes, Biomarkers, Cohort, Diabetes Risk Score, Diabetes Mellitus, Type 2, Glucose Intolerance, Prediabetic State
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- 23 Nov 2017 (actual)
- Study completion
- 23 Nov 2017 (actual)
- First posted
- 13 Sep 2011 (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 purpose of this study is to identify in prediabetic subjects, physiopathological changes involved in the evolution to type 2 diabetes mellitus and to identify new biomarkers of type 2 diabetes risk in this population.
Detailed description
Type 2 diabetes (T2D) is a real public health issue, with an exponential incidence. Before its diagnosis, several physiopathological changes are already taking place, such as insulin resistance of target tissues and the progressive inability of pancreatic beta cells to produce insulin. The objective of this study is a better understanding of the prediabetic stage and mechanisms involved in the possible development of T2D, by way of a five-year follow-up cohort study in 207 prediabetic subjects.
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 (1 listed)
- Previous history (within 2 months prior to enrollment visit) of fasting blood glucose ≥ 1,10 g/l and < 1,26 g/l OR fasting blood glucose ≥ 1 g/l and < 1,10 g/l with HbA1c ≥ 6,5%.
Key exclusion criteria (6 listed)
- Fasting glycemia ≥ 1.26 g/l
- History of treatment with oral antidiabetics
- History of treatment with insulin, except gestational diabetes
- Subject with any history or presence of significant hematologic (coagulation, thrombopenia, …), hepatic, renal, or psychiatric disorders
- Subject unable to follow the study during the 5 years of follow-up
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 |
|---|---|---|
| Prediabetes screening and prospective follow-up over 5 yearsThe study period per patient is 5 years. The planned schedule of the study is as follows : * Enrollment at visit V0 of subjects at high metabolic risk, based on a biological value (within the past 2 months) of moderate fasting hyperglycaemia (blood glucose ≥ 1,10 g/l and < 1,26 g/l) or fasting blood glucose ≥ 1 g/l and < 1,10 g/l with HbA1c ≥ 6,5%. * First biological sample (B0) within 1 month following V0 (measuring fasting blood glucose + glycated hemoglobin HbA1c + lipid profile + creatinemia + liver function; and establishment of a biological sample collection to identify biomarkers). * Annual follow-up for five years consisting in one blood sample (B1 to B5) measuring the same parameters as V0 + biological sample collection, and questionnaire on major health events or health events related to study procedures. * End of study phone call | Other | – |
Primary outcome
Type 2 Diabetes occurrence
Time frame: 5 years (or less if occurrence of the condition)
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
Biomarkers
Time frame: 7 to 10 years
Number of patients with pre-diabetes in North of France
Time frame: 5 years
HbA1c measurement
Time frame: 5 years
Diabetes Risk Score
Time frame: 5 years
Others cardiovascular risk factors
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
- 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 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 of Nantes, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prediabetes screening and prospective follow-up over 5 years in people with Prediabetes, 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 1 inclusion and 6 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: finished, as of the sponsor's last update on 6 Apr 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Type 2 Diabetes occurrence (time frame: 5 years (or less if occurrence of the condition)). 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 NCT01432509, which also lists 2 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 6 Apr 2018; AzTrials last refreshed its copy on 8 Nov 2026.