Clinical trial NCT01432509: Prospective Follow-up of a Cohort of Pre-diabetics in the North of France (DiabeNord)
Official title: DiabeNord: A 5-year Prospective Follow-up Cohort Study in Pre-diabetic Subjects for the Identification of New Biomarkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetes
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
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2011-09-13
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Type 2 Diabetes occurrence
timeFrame: 5 years (or less if occurrence of the condition)
Secondary outcomes:
measure: Biomarkers
timeFrame: 7 to 10 years
measure: Number of patients with pre-diabetes in North of France
timeFrame: 5 years
measure: HbA1c measurement
timeFrame: 5 years
measure: Diabetes Risk Score
timeFrame: 5 years
measure: Others cardiovascular risk factors
timeFrame: 5 years
Other outcomes:
Locations:
city: Lille
country: France
facility: Clinical Nutrition Center Naturalpha (CNCN)
Study officials:
affiliation: University Hospital of Nantes, France
name: Bertrand Cariou, Pr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Croyal M, Wargny M, Chemello K, Chevalier C, Blanchard V, Bigot-Corbel E, Lambert G, Le May C, Hadjadj S, Cariou B. Plasma apolipoprotein concentrations and incident diabetes in subjects with prediabetes. Cardiovasc Diabetol. 2022 Feb 7;21(1):21. doi: 10.1186/s12933-022-01452-5.
citation: Wargny M, Smati S, Pichelin M, Bigot-Corbel E, Authier C, Dierry V, Zair Y, Jacquin V, Hadjadj S, Boursier J, Cariou B. Fatty liver index is a strong predictor of changes in glycemic status in people with prediabetes: The IT-DIAB study. PLoS One. 2019 Aug 29;14(8):e0221524. doi: 10.1371/journal.pone.0221524. eCollection 2019.