NCT01432509

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2011

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2017

Completed
Last Updated

April 6, 2018

Status Verified

April 1, 2018

Enrollment Period

6.2 years

First QC Date

September 9, 2011

Last Update Submit

April 5, 2018

Conditions

Prediabetes

Keywords

Pre-diabetesType 2 diabetesBiomarkersCohortDiabetes Risk ScoreDiabetes Mellitus, Type 2Glucose IntolerancePrediabetic StateGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesHyperglycemia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Biomarkers

    7 to 10 years

  • Number of patients with pre-diabetes in North of France

    5 years

  • HbA1c measurement

    5 years

  • Diabetes Risk Score

    5 years

  • Others cardiovascular risk factors

    5 years

Interventions

Prediabetes screening and prospective follow-up over 5 yearsOTHER

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Center Naturalpha (CNCN)

Lille, 59020, France

Location

Related Publications (2)

  • 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.

    PMID: 35130909DERIVED

  • 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.

    PMID: 31465427DERIVED

MeSH Terms

Conditions

Prediabetic StateGlucose IntoleranceDiabetes Mellitus, Type 2Glucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesHyperglycemia

Condition Hierarchy (Ancestors)

Diabetes MellitusNutritional and Metabolic Diseases

Study Officials

  • Bertrand Cariou, Pr.

    University Hospital of Nantes, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2011

First Posted

September 13, 2011

Study Start

September 1, 2011

Primary Completion

November 23, 2017

Study Completion

November 23, 2017

Last Updated

April 6, 2018

Record last verified: 2018-04

Locations

FR(1)