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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2017-11-23

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Prediabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No