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

Primary Purpose

Prediabetes

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Prediabetes screening and prospective follow-up over 5 years

About this trial

This is an interventional diagnostic trial for Prediabetes focused on measuring Pre-diabetes, Type 2 diabetes, Biomarkers, Cohort, Diabetes Risk Score, Diabetes Mellitus, Type 2, Glucose Intolerance, Prediabetic State, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Hyperglycemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Clinical Nutrition Center Naturalpha (CNCN)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Biomarkers

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

To estimate the prevalence of prediabetes in the region Nord-Pas-de-Calais (France)

HbA1c measurement

To evaluate the role of HbA1c in screening for pre-diabetes and type 2 diabetes

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

Others cardiovascular risk factors

To measure the prevalence of other cardiovascular risk factors observed along with prediabetes: dyslipidemia, metabolic hepatopathy

Full Information

NCT ID

NCT01432509

First Posted

September 9, 2011

Last Updated

April 5, 2018

Sponsor

Nantes University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01432509

Brief Title

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

Acronym

DiabeNord

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

November 23, 2017 (Actual)

Study Completion Date

November 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nantes University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prediabetes

Keywords

Pre-diabetes, Type 2 diabetes, Biomarkers, Cohort, Diabetes Risk Score, Diabetes Mellitus, Type 2, Glucose Intolerance, Prediabetic State, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Hyperglycemia

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

207 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Other

Intervention Name(s)

Prediabetes screening and prospective follow-up over 5 years

Intervention Description

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

Primary Outcome Measure Information:

Title

Type 2 Diabetes occurrence

Description

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

Time Frame

5 years (or less if occurrence of the condition)

Secondary Outcome Measure Information:

Title

Biomarkers

Description

To highlight biomarkers of prediabetes, type 2 diabetes and cardiometabolic diseases, through genomics, proteomics and transcriptomics analyses performed on a biological sample collection.

Time Frame

7 to 10 years

Title

Number of patients with pre-diabetes in North of France

Description

To estimate the prevalence of prediabetes in the region Nord-Pas-de-Calais (France)

Time Frame

5 years

Title

HbA1c measurement

Description

To evaluate the role of HbA1c in screening for pre-diabetes and type 2 diabetes

Time Frame

5 years

Title

Diabetes Risk Score

Description

To assess the interest of Diabetes Risk Score (questionnaire used to evaluate a clinical risk) in identifying subjects at risk of type 2 diabetes

Time Frame

5 years

Title

Others cardiovascular risk factors

Description

To measure the prevalence of other cardiovascular risk factors observed along with prediabetes: dyslipidemia, metabolic hepatopathy

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bertrand Cariou, Pr.

Organizational Affiliation

University Hospital of Nantes, France

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinical Nutrition Center Naturalpha (CNCN)

City

Lille

ZIP/Postal Code

59020

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

35130909

Citation

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.

Results Reference

derived

PubMed Identifier

31465427

Citation

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.

Results Reference

derived

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

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