Overview

This trial is active, not recruiting.

Condition prediabetes
Treatment prediabetes screening and prospective follow-up over 5 years
Sponsor Nantes University Hospital
Start date September 2011
End date December 2017
Trial size 207 participants
Trial identifier NCT01432509, ID-RCB Number : 2011-A00565-36, RC12_0385

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic

Primary Outcomes

Measure
Type 2 Diabetes occurrence
time frame: 5 years (or less if occurrence of the condition)

Secondary Outcomes

Measure
Biomarkers
time frame: 7 to 10 years
Number of patients with pre-diabetes in North of France
time frame: 5 years
HbA1c measurement
time frame: 5 years
Diabetes Risk Score
time frame: 5 years
Others cardiovascular risk factors
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title DiabeNord: A 5-year Prospective Follow-up Cohort Study in Pre-diabetic Subjects for the Identification of New Biomarkers
Principal investigator Bertrand Cariou, Pr.
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Nantes University Hospital.