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. Identifier: NCT01432509
Recruitment Status : Completed
First Posted : September 13, 2011
Last Update Posted : April 6, 2018
Information provided by (Responsible Party):
Nantes University Hospital

September 9, 2011
September 13, 2011
April 6, 2018
September 2011
November 23, 2017   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01432509 on Archive Site
  • 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
Same as current
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Prospective Follow-up of a Cohort of Pre-diabetics in the North of France (DiabeNord)
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.
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.
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Other: Prediabetes screening and prospective follow-up over 5 years

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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 23, 2017
November 23, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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%.

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
ID-RCB Number : 2011-A00565-36 ( Other Identifier: Afssaps - French Health Products Safety Agency )
Not Provided
Not Provided
Nantes University Hospital
Nantes University Hospital
Not Provided
Principal Investigator: Bertrand Cariou, Pr. University Hospital of Nantes, France
Nantes University Hospital
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP