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

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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Menopause

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 1200

Contacts and Locations

• Study Contact: Name: Chii-Min Hwu, MD; Phone Number: 886228757516; Email: chhwu@vghtpe.gov.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 112
    • Recruiting
    • Taipei Veterans General Hospital
    • Principal Investigator: Chii-Min Hwu, MD
    • Contact: Chii-Min Hwu, MD; Phone Number: 8862287516; Email: chhwu@vghtpe.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Premenopausal Women; 600 health premenopausal Women
Postmenopausal women; 600 healthy postmenopausal women

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
genetic associations with body-mass index and waist circumference.	genetic associations with body-mass index and waist circumference.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
genetic associations with body fat composition	genetic associations with body fat composition, measured by DEXA	3 years
genetic associations with the metabolic syndrome	genetic associations with the metabolic syndrome	3 years

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Collaborators: National Yang Ming University
• Investigators: Principal Investigator: Chii-Min Hwu, MD, Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Anticipated): July 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: December 6, 2011
• First Submitted That Met QC Criteria: December 6, 2011
• First Posted (Estimate): December 8, 2011

Study Record Updates

• Last Update Posted (Estimate): December 14, 2011
• Last Update Submitted That Met QC Criteria: December 12, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: obesity; body composition; women; genetic susceptibility; the metabolic syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Disease Susceptibility; Genetic Predisposition to Disease
• Other Study ID Numbers: 2011-06-013GA