- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01488903
A Cohort Research of Genetic Susceptibility for Common Obesity in Women (CROWN)
12. desember 2011 oppdatert av: vghtpe user, Taipei Veterans General Hospital, Taiwan
A Cohort Research of Genetic Susceptibility for Common Obesity in Women (CROWN Study)
Not many studies examined genetic determinants of obesity in women.
As pre-menopausal and post-menopausal women appear to have different propensities for fat deposition, genetic loci linked with obesity-related phenotypes might be different by menopausal status.
So far, there is no large scale of genetic study deciphering common obesity focusing on women population to examine the contributions of aging and change in menopausal status to obesity in Taiwan.
The investigators propose this study to compare phenotypic profiles of obesity and cardio-metabolic factors in pre-menopausal and post-menopausal women.
The study will examine the contributions of aging and change in menopausal status to the changes of obesity-related traits during the transition from pre-menopause to post-menopause period, and will evaluate the contribution of genetic susceptibility on body fat deposition among women at different stage of menopause.
Studieoversikt
Status
Ukjent
Forhold
Detaljert beskrivelse
Not many studies examined genetic determinants of obesity in women.
As premenopausal and postmenopausal women appear to have different propensities for fat deposition, genetic loci linked with obesity-related phenotypes might be different by menopausal status.
So far, there is no large scale of genetic study deciphering common obesity on women focusing on the interaction between aging and menopause in Taiwan.
The investigators propose this study to compare phenotypic profiles of obesity and cardiometabolic factors in a large group of premenopausal and postmenopausal women.
The study will examine the contributions of aging and menopausal status to the changes of obesity-related traits, and will evaluate the contribution of genetic susceptibility on body fat deposition among women at different stage of menopause.
The investigators plan to recruit two groups of subjects: 600 premenopausal, and 600 postmenopausal women.
Each woman will receive anthropometric and blood pressure measurements, fasting blood sampling for lipids, and an optional 75-g oral glucose tolerance test for insulin resistance.
Dual energy X-ray absorptiometry will also be used for body composition measurements among the study women if they agree to receive this optional examination.
The investigators will collect blood samples for DNA extraction and select several candidate genes to study the associations between susceptible genes and obesity-related traits.
The investigators anticipate that the results generated from the study will provide valuable data to a better understanding of the pathogenesis of common obesity during transition from premenopause to postmenopause in women.
Studietype
Observasjonsmessig
Registrering (Forventet)
1200
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Taipei, Taiwan, 112
- Rekruttering
- Taipei Veterans General Hospital
-
Hovedetterforsker:
- Chii-Min Hwu, MD
-
Ta kontakt med:
- Chii-Min Hwu, MD
- Telefonnummer: 8862287516
- E-post: chhwu@vghtpe.gov.tw
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
35 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Hunn
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
The design of the project is a hospital-based case-control study.
We will recruit two study groups: 600 post-menopausal women; 600 premenopausal women.
Beskrivelse
Inclusion Criteria:
- Premenopausal Women Group
- Age: 35 ~ 50 years old
- Subjects have menstrual period
- Subjects are not pregnant
- Subject is willing to sign inform consent
- Postmenopausal Women Group
- Age: 50 ~ 65 years old
- Women who have not menstruated within the last 12 months
- Subject is willing to sign inform consent.
Exclusion Criteria:
- Pregnant women
- Women with known diabetes and fasting plasma glucose (PG) higher than 126 mg/dL
- Women have liver, kidney, heart and neurological diseases, as well as they have history of hyper- and hypothyroidism
- Subject has acute illness in the past 6 months
- Subject has history of alcohol or substance abuse
- Taking concomitant medication including hormone replacement and anti-lipid agents in two weeks
- Women with difficult giving venous blood sample
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
Premenopausal Women
600 health premenopausal Women
|
|
Postmenopausal women
600 healthy postmenopausal women
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
genetic associations with body-mass index and waist circumference.
Tidsramme: 3 years
|
genetic associations with body-mass index and waist circumference.
|
3 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
genetic associations with body fat composition
Tidsramme: 3 years
|
genetic associations with body fat composition, measured by DEXA
|
3 years
|
|
genetic associations with the metabolic syndrome
Tidsramme: 3 years
|
genetic associations with the metabolic syndrome
|
3 years
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Chii-Min Hwu, MD, Taipei Veterans General Hospital, Taiwan
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2011
Primær fullføring (Forventet)
1. juli 2014
Studiet fullført (Forventet)
1. desember 2014
Datoer for studieregistrering
Først innsendt
6. desember 2011
Først innsendt som oppfylte QC-kriteriene
6. desember 2011
Først lagt ut (Anslag)
8. desember 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
14. desember 2011
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. desember 2011
Sist bekreftet
1. desember 2011
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2011-06-013GA
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .