Prediabetes
Conditions
Keywords
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
Brief summary
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
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.
Interventions
OTHERPrediabetes 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
Sponsors
Nantes University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Type 2 Diabetes occurrence | 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
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers | 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 | 5 years | To estimate the prevalence of prediabetes in the region Nord-Pas-de-Calais (France) |
| HbA1c measurement | 5 years | To evaluate the role of HbA1c in screening for pre-diabetes and type 2 diabetes |
| Diabetes Risk Score | 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 | 5 years | To measure the prevalence of other cardiovascular risk factors observed along with prediabetes: dyslipidemia, metabolic hepatopathy |
Countries
France
Outcome results
None listed