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

NCT02542735 | Completed

• 1 other identifier: PI14/00710
• Study Type: observational
• Target: 2,408
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Risk of diabetes according to each of the measured SNP

  6 years on average

• Risk of metabolic syndrome according to each of the measured SNP

  6 years on average

Study Arms (1)

Spanish di@bet.es cohort

Representative of Spanish population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• General Population

You may not qualify if:

• diabetes in cross-sectional study
• serious illness that prevents participation
• pregnancy
• surgery within the previous month
• any other disabling situation that prevents participation

Sponsors & Collaborators

• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud: lead
• Instituto de Salud Carlos III: collaborator
• Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders: collaborator

Study Sites (1)

Hospital Regional Universitario

Málaga, Malaga, 29009, Spain

Location

Related Publications (1)

• 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.

  PMID: 21987347 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood Serum and DNA

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: September 3, 2015
• First Posted: September 7, 2015
• Study Start: November 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: November 1, 2019
• Last Updated: December 3, 2019

Record last verified: 2019-11

Locations

ES (1)