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.

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2

• Study Type: Observational
• Enrollment (Actual): 2408

Contacts and Locations

Study Locations

• Spain
  • Malaga
    • Málaga, Malaga, Spain, 29009
      • Hospital Regional Universitario

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Spanish di@bet.es cohort; Representative of Spanish population

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• 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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): November 1, 2019

Study Registration Dates

• First Submitted: September 3, 2015
• First Submitted That Met QC Criteria: September 3, 2015
• First Posted (Estimate): September 7, 2015

Study Record Updates

• Last Update Posted (Actual): December 3, 2019
• Last Update Submitted That Met QC Criteria: November 29, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: PI14/00710