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Completed

NCT Number: NCT01432509

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

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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Key information

Conditions

PreDiabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Nutrition Center Naturalpha (CNCN)

Lille, 59020, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prediabetes screening and prospective follow-up over 5 years

Other

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 outcomes

  1. Type 2 Diabetes occurrence

    Time frame: 5 years (or less if occurrence of the condition)

    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 outcomes

  1. Biomarkers

    Time frame: 7 to 10 years

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

  2. Number of patients with pre-diabetes in North of France

    Time frame: 5 years

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

  3. HbA1c measurement

    Time frame: 5 years

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

  4. Diabetes Risk Score

    Time frame: 5 years

    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. Others cardiovascular risk factors

    Time frame: 5 years

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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: DiabeNord

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Sep 13, 2011
Registry last updated
Apr 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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