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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02542735
Recruitment Status : Completed
First Posted : September 7, 2015
Last Update Posted : December 3, 2019
Sponsor:
Collaborators:
Instituto de Salud Carlos III
Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders
Information provided by (Responsible Party):
Gemma Rojo, 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.

Condition or disease
Diabetes Mellitus, Type 2

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Study Type : Observational
Actual Enrollment : 2408 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Study Start Date : November 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Type 2 diabetes incidence [ Time Frame: 6 years on average ]
    Presence of type 2 diabetes mellitus diagnosed by OGTT after 6 years of follow up in a Spanish population.

  2. Metabolic syndrome incidence [ Time Frame: 6 years on average ]
    Presence of metabolic syndrome (according ATPIII criteria) after 6 years of follow up in a Spanish population.


Secondary Outcome Measures :
  1. Risk of diabetes according to each of the measured SNP [ Time Frame: 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.

  2. Risk of metabolic syndrome according to each of the measured SNP [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
Blood Serum and DNA


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02542735


Locations
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Spain
Hospital Regional Universitario
Málaga, Malaga, Spain, 29009
Sponsors and Collaborators
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

Publications:
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Responsible Party: Gemma Rojo, Senior Researcher, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
ClinicalTrials.gov Identifier: NCT02542735    
Other Study ID Numbers: PI14/00710
First Posted: September 7, 2015    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases