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CompletedNCT02542735Updated Dec 3, 2019

Incidence of Type 2 Diabetes in the di@Bet.es Study

An observational study in Diabetes Mellitus, Type 2, sponsored by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-03.

Sponsored by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,408
Ages
18 Years and older
Sex
All
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Study summary

Our aim was to determine the incidence of type 2 diabetes mellitus in a nation-wide population based cohort from Spain (di@bet.es 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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Conditions studied

  • Diabetes Mellitus, Type 2
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In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 2,408 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud is the lead sponsor of 71 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The study is based on the di@bet.es study, a cross-sectional study undertaken from 2007-2010 from a random cluster sampling in the Spanish population over 18 years of age (Soriguer et al. Diabetologia 2012;55(1):88-93).

Inclusion criteria

  • General Population

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,408 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Spanish di@bet.es cohort

    Representative of Spanish population

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What researchers measure

Primary outcomes

  1. Type 2 diabetes incidence

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

    Time frame: 6 years on average

  2. Metabolic syndrome incidence

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

    Time frame: 6 years on average

Secondary outcomes

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

    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.

    Time frame: 6 years on average

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

    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.

    Time frame: 6 years on average

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Study locations

1 site
  • Hospital Regional Universitario
    Málaga, Malaga 29009, Spain
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References and documents

Publications

  • Soriguer F, Goday A, Bosch-Comas A, Bordiu E, Calle-Pascual A, Carmena R, Casamitjana R, Castano L, Castell C, Catala M, Delgado E, Franch J, Gaztambide S, Girbes J, Gomis R, Gutierrez G, Lopez-Alba A, Martinez-Larrad MT, Menendez E, Mora-Peces I, Ortega E, Pascual-Manich G, Rojo-Martinez G, Serrano-Rios M, Valdes S, Vazquez JA, Vendrell J. Prevalence of diabetes mellitus and impaired glucose regulation in Spain: the Di@bet.es Study. Diabetologia. 2012 Jan;55(1):88-93. doi: 10.1007/s00125-011-2336-9. Epub 2011 Oct 11. PubMed 21987347 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02542735
Lead sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Collaborators
Instituto de Salud Carlos III, Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders
Responsible party
Gemma Rojo (Senior Researcher, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud) — Principal investigator
First posted
Sep 7, 2015
Start date
Nov 2015
Primary completion
Dec 2017
Completion
Nov 2019
Last update
Dec 3, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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