Prospective Follow-up of a Cohort of Pre-diabetics in the North of France (DiabeNord)
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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 Primary Purpose: Diagnostic |
| Official Title: | DiabeNord: A 5-year Prospective Follow-up Cohort Study in Pre-diabetic Subjects for the Identification of New Biomarkers |
- 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
- 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) |
-
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 visit
The study period per patient is 5 years. The planned schedule of the study is as follows :
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 |
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| France | |
| Clinical Nutrition Center Naturalpha (CNCN) | |
| Lille, France, 59020 | |
| 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: | March 5, 2013 |
| 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 May 16, 2013