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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01432509
First received: September 9, 2011
Last updated: April 3, 2014
Last verified: April 2014

September 9, 2011
April 3, 2014
September 2011
December 2017   (final data collection date for primary outcome measure)
Type 2 Diabetes occurrence [ Time Frame: 5 years (or less if occurrence of the condition) ] [ Designated as safety issue: No ]
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 ClinicalTrials.gov Archive Site
  • Biomarkers [ Time Frame: 7 to 10 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To estimate the prevalence of prediabetes in the region Nord-Pas-de-Calais (France)
  • HbA1c measurement [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To evaluate the role of HbA1c in screening for pre-diabetes and type 2 diabetes
  • Diabetes Risk Score [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To measure the prevalence of other cardiovascular risk factors observed along with prediabetes: dyslipidemia, metabolic hepatopathy
Same as current
Not Provided
Not Provided
 
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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Prediabetes
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 visit
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
207
December 2017
December 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01432509
12_0385, ID-RCB Number : 2011-A00565-36
No
Nantes University Hospital
Nantes University Hospital
Not Provided
Study Chair: Bertrand Cariou, Pr. University Hospital of Nantes, France
Principal Investigator: Xavier Deplanque, MD Clinical Nutrition Center Naturalpha, France
Nantes University Hospital
April 2014

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