- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01488903
A Cohort Research of Genetic Susceptibility for Common Obesity in Women (CROWN)
12 december 2011 uppdaterad 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.
Studieöversikt
Status
Okänd
Betingelser
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Förväntat)
1200
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Taipei, Taiwan, 112
- Rekrytering
- Taipei Veterans General Hospital
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Huvudutredare:
- Chii-Min Hwu, MD
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Kontakt:
- Chii-Min Hwu, MD
- Telefonnummer: 8862287516
- E-post: chhwu@vghtpe.gov.tw
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
35 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Kvinna
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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Premenopausal Women
600 health premenopausal Women
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Postmenopausal women
600 healthy postmenopausal women
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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genetic associations with body-mass index and waist circumference.
Tidsram: 3 years
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genetic associations with body-mass index and waist circumference.
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3 years
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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genetic associations with body fat composition
Tidsram: 3 years
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genetic associations with body fat composition, measured by DEXA
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3 years
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genetic associations with the metabolic syndrome
Tidsram: 3 years
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genetic associations with the metabolic syndrome
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3 years
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Chii-Min Hwu, MD, Taipei Veterans General Hospital, Taiwan
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 september 2011
Primärt slutförande (Förväntat)
1 juli 2014
Avslutad studie (Förväntat)
1 december 2014
Studieregistreringsdatum
Först inskickad
6 december 2011
Först inskickad som uppfyllde QC-kriterierna
6 december 2011
Första postat (Uppskatta)
8 december 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
14 december 2011
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 december 2011
Senast verifierad
1 december 2011
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2011-06-013GA
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .