- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00949416
Risk Factors of Incidence of Type 2 Diabetes and Cardiovascular Diseases---Shanghai Baoshan Study (SBSS)
29. juli 2009 opdateret af: Shanghai Jiao Tong University School of Medicine
Risk Factors of Incidence of Type 2 Diabetes and Cardiovascular Diseases
Objective: Recruit 3 cohorts with 1000-1200 subjects each: people with normal glucose metabolism, impaired glucose regulation (IGR), and with Type 2 diabetes.
To study the risk factors in development of type 2 diabetes.
Studieoversigt
Status
Ukendt
Betingelser
Detaljeret beskrivelse
Methods:
We aim to perform a two-step blood glucose survey in 2008-2009 in a population selected from a single urban community of Shanghai. The Institutional Review Board of the Rui-Jin Hospital approved the study protocol. Informed consent will be obtained from each participant.
- In the first step, we first invited all registered permanent residents aged 40 or above by local poster advertisement and by mail to participate in a screening examination, during which we collected information on lifestyle, medical history and the use of medications using a questionnaire, and performed anthropometrical measurements and fasting glucose measurement. The first step of diabetes screening finished in June, 2008.
- In the second step, after exclusion of subjects with self-reported diabetes, we classified the screened subjects into 3 groups according to their fasting plasma glucose concentration of 7.0 mmol/L or above, 5.0 to 6.9 mmol/L or below 5.0 mmol/L. We selected randomly a sample from these 3 subgroups for further investigation including a 75-g oral glucose tolerance test (OGTT) and blood and urine sampling and other vascular functional measurements. Our selection was based on a ratio of 1:1.2:1.44, because of the concern that by knowing the results of fasting plasma glucose test, subjects with lower glucose levels might have a lower participation rate than those with higher glucose concentrations. Nevertheless, this ratio was arbitrarily chosen. Finally, 1000 Type 2 diabetic patients, 1200 subjects with IGR and 1440 subjects with normal glucose metabolism were selected as target population of this study by random sampling for further blood and urine sampling.
- Biomarkers and genetic risk factors will be evaluated in the study subjects.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
3000
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
40 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
1000 Type 2 diabetic patients, 1200 subjects with IGR and 1440 subjects with normal glucose metabolism (aged above 40 years old, both men and women)were selected as target population of this study by random sampling.
Beskrivelse
Inclusion Criteria:
- aged above 40 years
Exclusion Criteria:
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studiestol: Guang Ning, MD, PHD, Shanghai Clinical Centre for Endocrinology and Metabolism
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. juni 2009
Primær færdiggørelse (Forventet)
1. september 2009
Studieafslutning (Forventet)
1. september 2009
Datoer for studieregistrering
Først indsendt
29. juli 2009
Først indsendt, der opfyldte QC-kriterier
29. juli 2009
Først opslået (Skøn)
30. juli 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
30. juli 2009
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. juli 2009
Sidst verificeret
1. juli 2009
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CCEMD007
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 .
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