A Cohort Research of Genetic Susceptibility for Common Obesity in Women

Obesity Clinical Trial

— CROWN  

Official title:

A Cohort Research of Genetic Susceptibility for Common Obesity in Women (CROWN Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01488903
• Other study ID #: 2011-06-013GA
• Status: Recruiting
• Phase: N/A
• First received: December 6, 2011
• Last updated: December 12, 2011
• Start date: September 2011
• Est. completion date: December 2014

Study information

• Verified date: December 2011
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Chii-Min Hwu, MD
• Phone: 886228757516
• Email: chhwu[@]vghtpe.gov.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of HealthTaiwan: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Disease Susceptibility
• Genetic Predisposition to Disease
• Menopause
• Obesity

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan	National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	genetic associations with body-mass index and waist circumference.	genetic associations with body-mass index and waist circumference.	3 years	No
Secondary	genetic associations with body fat composition	genetic associations with body fat composition, measured by DEXA	3 years	No
Secondary	genetic associations with the metabolic syndrome	genetic associations with the metabolic syndrome	3 years	No