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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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DiabeNord: A 5-year Prospective Follow-up Cohort Study in Pre-diabetic Subjects for the Identification of New Biomarkers

Conditions
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Prediabetes

Intervention / Treatment
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* Other: Prediabetes screening and prospective follow-up over 5 years


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type 2 Diabetes occurrence | 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 | 5 years (or less if occurrence of the condition) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers | To highlight biomarkers of prediabetes, type 2 diabetes and cardiometabolic diseases, through genomics, proteomics and transcriptomics analyses performed on a biological sample collection. | 7 to 10 years | 
| Number of patients with pre-diabetes in North of France | To estimate the prevalence of prediabetes in the region Nord-Pas-de-Calais (France) | 5 years | 
| HbA1c measurement | To evaluate the role of HbA1c in screening for pre-diabetes and type 2 diabetes | 5 years | 
| Diabetes Risk Score | To assess the interest of Diabetes Risk Score (questionnaire used to evaluate a clinical risk) in identifying subjects at risk of type 2 diabetes | 5 years | 
| Others cardiovascular risk factors | To measure the prevalence of other cardiovascular risk factors observed along with prediabetes: dyslipidemia, metabolic hepatopathy | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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