MedTrace Logo

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

NCT01432509 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2018-04-06

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Bertrand Cariou, Pr. · University Hospital of Nantes, France

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2017-11-23
Completion
2017-11-23

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01432509 on ClinicalTrials.gov