Clinical trial NCT02542735: Incidence of Type 2 Diabetes in the di@Bet.es Study
Official title: Incidence of Type 2 Diabetes in the di@Bet.es Study: Role of Fatty Acid Transport System Regulated by VEGFB in the Development of Metabolic Diseases.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders
First posted: 2015-09-07
Enrollment: 2408
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Type 2 diabetes incidence
timeFrame: 6 years on average
measure: Metabolic syndrome incidence
timeFrame: 6 years on average
Secondary outcomes:
measure: Risk of diabetes according to each of the measured SNP
timeFrame: 6 years on average
measure: Risk of metabolic syndrome according to each of the measured SNP
timeFrame: 6 years on average
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Hospital Regional Universitario
state: Malaga
Study officials:
References:
citation: 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.