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

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT02542735
• Lead Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-03
• Study First Submitted QC: 2015-09-03
• Study First Posted: 2015-09-07
• Study Start: 2015-11
• Primary Completion: 2017-12
• Status Verified: 2019-11
• Study Completion: 2019-11
• Last Update Submitted: 2019-11-29
• Last Update Posted: 2019-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2408

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Type 2 diabetes incidence	6 years on average	Presence of type 2 diabetes mellitus diagnosed by OGTT after 6 years of follow up in a Spanish population.
Metabolic syndrome incidence	6 years on average	Presence of metabolic syndrome (according ATPIII criteria) after 6 years of follow up in a Spanish population.

Secondary Outcome Measures

Name	Time	Method
Risk of diabetes according to each of the measured SNP	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.
Risk of metabolic syndrome according to each of the measured SNP	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.

Trial Locations

Locations (1)

Hospital Regional Universitario; 🇪🇸 Málaga, Malaga, Spain