Prospective Follow-up of a Cohort of Pre-diabetics in the North of France (DiabeNord) (DiabeNord)
|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
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|