Clinical Trials Directory

Trials / Completed

CompletedNCT02542735

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

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.

Status
Completed
Phase
Study type
Observational
Enrollment
2,408 (actual)
Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2015-11-01
Primary completion
2017-12-01
Completion
2019-11-01
First posted
2015-09-07
Last updated
2019-12-03

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT02542735. Inclusion in this directory is not an endorsement.