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

Not Applicable

Completed

• Conditions: Prediabetes

• Registration Number: NCT01432509
• Lead Sponsor: Nantes University Hospital

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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-09
• Study First Submitted QC: 2011-09-09
• Study First Posted: 2011-09-13
• Primary Completion: 2017-11-23
• Study Completion: 2017-11-23
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-05
• Last Update Posted: 2018-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Clinical Nutrition Center Naturalpha (CNCN); 🇫🇷 Lille, France