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

Diabetes Mellitus, Type 2 Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02542735
• Other study ID #: PI14/00710
• Status: Completed
• Start date: November 2015
• Est. completion date: November 2019

Study information

• Verified date: November 2019
• Source: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2408
• Est. completion date: November 2019
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Locations

Country	Name	City	State
Spain	Hospital Regional Universitario	Málaga	Malaga

Sponsors (3)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud	Instituto de Salud Carlos III, Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Soriguer F, Goday A, Bosch-Comas A, Bordiú E, Calle-Pascual A, Carmena R, Casamitjana R, Castaño L, Castell C, Catalá M, Delgado E, Franch J, Gaztambide S, Girbés J, Gomis R, Gutiérrez G, López-Alba A, Martínez-Larrad MT, Menéndez E, Mora-Peces I, Ortega E, Pascual-Manich G, Rojo-Martínez G, Serrano-Rios M, Valdés S, Vázquez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type 2 diabetes incidence	Presence of type 2 diabetes mellitus diagnosed by OGTT after 6 years of follow up in a Spanish population.	6 years on average
Primary	Metabolic syndrome incidence	Presence of metabolic syndrome (according ATPIII criteria) after 6 years of follow up in a Spanish population.	6 years on average
Secondary	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.	6 years on average
Secondary	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.	6 years on average