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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01432509
First Posted: September 13, 2011
Last Update Posted: June 24, 2016
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.
Information provided by (Responsible Party):
Nantes University Hospital
  Purpose
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.

Condition Intervention
Prediabetes Other: Prediabetes screening and prospective follow-up over 5 years

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: DiabeNord: A 5-year Prospective Follow-up Cohort Study in Pre-diabetic Subjects for the Identification of New Biomarkers

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 207
Study Start Date: September 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
France
Clinical Nutrition Center Naturalpha (CNCN)
Lille, France, 59020
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Bertrand Cariou, Pr. University Hospital of Nantes, France
  More Information

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01432509     History of Changes
Other Study ID Numbers: RC12_0385
ID-RCB Number : 2011-A00565-36 ( Other Identifier: Afssaps - French Health Products Safety Agency )
First Submitted: September 9, 2011
First Posted: September 13, 2011
Last Update Posted: June 24, 2016
Last Verified: June 2016

Keywords provided by Nantes University Hospital:
Pre-diabetes
Glucose Intolerance
Prediabetic State
Type 2 diabetes
Biomarkers
Cohort
Diabetes Risk Score
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia

Additional relevant MeSH terms:
Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases


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