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

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

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.

Study Overview

• Status: Completed
• Conditions: Prediabetes
• Intervention / Treatment: Other: Prediabetes screening and prospective follow-up over 5 years

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 Type: Interventional
• Enrollment (Actual): 207
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France, 59020
    • Clinical Nutrition Center Naturalpha (CNCN)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Bertrand Cariou, Pr., University Hospital of Nantes, France

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): November 23, 2017
• Study Completion (Actual): November 23, 2017

Study Registration Dates

• First Submitted: September 9, 2011
• First Submitted That Met QC Criteria: September 9, 2011
• First Posted (Estimate): September 13, 2011

Study Record Updates

• Last Update Posted (Actual): April 6, 2018
• Last Update Submitted That Met QC Criteria: April 5, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Type 2 diabetes; Cohort; Hyperglycemia; Biomarkers; Diabetes Mellitus, Type 2; Glucose Intolerance; Pre-diabetes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Risk Score; Prediabetic State
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: RC12_0385; ID-RCB Number : 2011-A00565-36 (Other Identifier: Afssaps - French Health Products Safety Agency)