- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02542735
Incidence of Type 2 Diabetes in the di@Bet.es Study
29. november 2019 opdateret af: Gemma Rojo, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
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.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
2408
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Malaga
-
Málaga, Malaga, Spanien, 29009
- Hospital Regional Universitario
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
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).
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Spanish di@bet.es cohort
Representative of Spanish population
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Type 2 diabetes incidence
Tidsramme: 6 years on average
|
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
Tidsramme: 6 years on average
|
Presence of metabolic syndrome (according ATPIII criteria) after 6 years of follow up in a Spanish population.
|
6 years on average
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Risk of diabetes according to each of the measured SNP
Tidsramme: 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.
|
6 years on average
|
|
Risk of metabolic syndrome according to each of the measured SNP
Tidsramme: 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.
|
6 years on average
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2015
Primær færdiggørelse (Faktiske)
1. december 2017
Studieafslutning (Faktiske)
1. november 2019
Datoer for studieregistrering
Først indsendt
3. september 2015
Først indsendt, der opfyldte QC-kriterier
3. september 2015
Først opslået (Skøn)
7. september 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. december 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. november 2019
Sidst verificeret
1. november 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PI14/00710
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .