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

Prediabetes Clinical Trial

— DiabeNord  

Official title:

DiabeNord: A 5-year Prospective Follow-up Cohort Study in Pre-diabetic Subjects for the Identification of New Biomarkers

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
• 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

Related Conditions & MeSH terms

• Prediabetes
• Prediabetic State

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