Prospective Follow-up of a Cohort of Pre-diabetics in the North of France (DiabeNord) (DiabeNord)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01432509|
Recruitment Status : Active, not recruiting
First Posted : September 13, 2011
Last Update Posted : June 24, 2016
|Condition or disease||Intervention/treatment|
|Prediabetes||Other: Prediabetes screening and prospective follow-up over 5 years|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||207 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||DiabeNord: A 5-year Prospective Follow-up Cohort Study in Pre-diabetic Subjects for the Identification of New Biomarkers|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Other: Prediabetes screening and prospective follow-up over 5 years
- 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
The study period per patient is 5 years. The planned schedule of the study is as follows :
- 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
- Biomarkers [ Time Frame: 7 to 10 years ]To highlight biomarkers of prediabetes, type 2 diabetes and cardiometabolic diseases, through genomics, proteomics and transcriptomics analyses performed on a biological sample collection.
- Number of patients with pre-diabetes in North of France [ Time Frame: 5 years ]To estimate the prevalence of prediabetes in the region Nord-Pas-de-Calais (France)
- HbA1c measurement [ Time Frame: 5 years ]To evaluate the role of HbA1c in screening for pre-diabetes and type 2 diabetes
- Diabetes Risk Score [ Time Frame: 5 years ]To assess the interest of Diabetes Risk Score (questionnaire used to evaluate a clinical risk) in identifying subjects at risk of type 2 diabetes
- Others cardiovascular risk factors [ Time Frame: 5 years ]To measure the prevalence of other cardiovascular risk factors observed along with prediabetes: dyslipidemia, metabolic hepatopathy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01432509
|Clinical Nutrition Center Naturalpha (CNCN)|
|Lille, France, 59020|
|Principal Investigator:||Bertrand Cariou, Pr.||University Hospital of Nantes, France|