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Completed

NCT Number: NCT02542735

Incidence of Type 2 Diabetes in the [email protected] Study

Our aim was to determine the incidence of type 2 diabetes mellitus in a nation-wide population based cohort from Spain ([email protected] study). The target was the Spanish population. The sample consisted of 5072 people older than 18 years, in 100 clusters (health centres randomly selected from all over Spain). The following variables were recorded: Socio-demographic and clinical data, survey on habits (physical activity and frequency of selected food consumption) and a physical examination was made (weight, height, waist, hip, blood pressure). A fasting blood draw and an oral glucose tolerance test were performed. Determinations of serum glucose were made. In the follow-up the same variables were collected and HbA1c was determined. A total of 2408 subjects participated in the follow-up (7.5±0.6 years, 39.7% men). In total, 154 people developed diabetes (6.4% cumulative incidence in the 7.5 years of follow-up). The incidence of total diabetes adjusted for the structure of age and sex of the Spanish population was 11.6 cases/1000 person-years (IC95%=11.1-12.1). The incidence of known diabetes was 3.7 cases/1000 person-years (IC95%=2.8-4.6) and the incidence of unknown diabetes was 7.9 cases/1000 person-years (IC95%=5.3-8.1). The main risk factors for developing diabetes were the presence of prediabetes in cross-sectional study, age, male sex, obesity, central obesity, increase in weight, and family history of diabetes. This work provides data about population-based incidence rates of diabetes and associated risk factors in a nation-wide cohort of Spanish population.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Regional Universitario

Málaga, Malaga, 29009, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • General Population

Exclusion criteria

  • diabetes in cross-sectional study
  • serious illness that prevents participation
  • pregnancy
  • surgery within the previous month
  • any other disabling situation that prevents participation

Treatment and study plan

Primary outcomes

  1. Type 2 diabetes incidence

    Time frame: 6 years on average

    Presence of type 2 diabetes mellitus diagnosed by OGTT after 6 years of follow up in a Spanish population.

  2. Metabolic syndrome incidence

    Time frame: 6 years on average

    Presence of metabolic syndrome (according ATPIII criteria) after 6 years of follow up in a Spanish population.

Secondary outcomes

  1. Risk of diabetes according to each of the measured SNP

    Time frame: 6 years on average

    To show that the presence of particular alleles of genes encoding fatty acid transporters and their regulatory proteins (VEGF-B) are associated with the risk of developing type 2 diabetes after six years of follow up.

  2. Risk of metabolic syndrome according to each of the measured SNP

    Time frame: 6 years on average

    To show that the presence of particular alleles of genes encoding fatty acid transporters and their regulatory proteins (VEGF-B) are associated with the risk of developing metabolic syndrome after six years of follow up.

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Other

Collaborators

  • Instituto de Salud Carlos III
  • Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders

Registry information

Official study title

Incidence of Type 2 Diabetes in the [email protected] Study: Role of Fatty Acid Transport System Regulated by VEGFB in the Development of Metabolic Diseases.

Important dates

Study start
2015
Primary completion
2017
Study completion
2019
First posted
Sep 7, 2015
Registry last updated
Dec 3, 2019

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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