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
  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: 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) ] [ 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


Secondary Outcome Measures:
  • 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


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 visit
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01432509

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

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01432509     History of Changes
Other Study ID Numbers: 12_0385, ID-RCB Number : 2011-A00565-36
Study First Received: September 9, 2011
Last Updated: April 3, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on July 29, 2014