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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01432509
Other study ID # RC12_0385
Secondary ID ID-RCB Number :
Status Completed
Phase N/A
First received September 9, 2011
Last updated April 5, 2018
Start date September 2011
Est. completion date November 23, 2017

Study information

Verified date April 2018
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 207
Est. completion date November 23, 2017
Est. primary completion date November 23, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France Clinical Nutrition Center Naturalpha (CNCN) Lille

Sponsors (1)

Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary HbA1c measurement To evaluate the role of HbA1c in screening for pre-diabetes and type 2 diabetes 5 years
Secondary 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
Secondary Others cardiovascular risk factors To measure the prevalence of other cardiovascular risk factors observed along with prediabetes: dyslipidemia, metabolic hepatopathy 5 years
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