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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2011 by Taipei Veterans General Hospital, Taiwan
Sponsor:
Collaborator:
National Yang Ming University
Information provided by (Responsible Party):
vghtpe user, Taipei Veterans General Hospital,Taiwan
ClinicalTrials.gov Identifier:
NCT01488903
First received: December 6, 2011
Last updated: December 12, 2011
Last verified: December 2011
  Purpose

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.


Condition
Obesity
Menopause

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: A Cohort Research of Genetic Susceptibility for Common Obesity in Women (CROWN Study)

Resource links provided by NLM:


Further study details as provided by Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • genetic associations with body-mass index and waist circumference. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    genetic associations with body-mass index and waist circumference.


Secondary Outcome Measures:
  • genetic associations with body fat composition [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    genetic associations with body fat composition, measured by DEXA

  • genetic associations with the metabolic syndrome [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    genetic associations with the metabolic syndrome


Biospecimen Retention:   Samples With DNA

DNA, fasting blood samples


Estimated Enrollment: 1200
Study Start Date: September 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Premenopausal Women
600 health premenopausal Women
Postmenopausal women
600 healthy postmenopausal women

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.

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01488903

Contacts
Contact: Chii-Min Hwu, MD 886228757516 chhwu@vghtpe.gov.tw

Locations
Taiwan
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 112
Contact: Chii-Min Hwu, MD    8862287516    chhwu@vghtpe.gov.tw   
Principal Investigator: Chii-Min Hwu, MD         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
National Yang Ming University
Investigators
Principal Investigator: Chii-Min Hwu, MD Taipei Veterans General Hospital, Taiwan
  More Information

No publications provided

Responsible Party: vghtpe user, Principal Investgator, Taipei Veterans General Hospital,Taiwan
ClinicalTrials.gov Identifier: NCT01488903     History of Changes
Other Study ID Numbers: 2011-06-013GA
Study First Received: December 6, 2011
Last Updated: December 12, 2011
Health Authority: Taiwan: Department of Health
Taiwan: Institutional Review Board

Keywords provided by Taipei Veterans General Hospital, Taiwan:
genetic susceptibility
obesity
body composition
the metabolic syndrome
women

Additional relevant MeSH terms:
Disease Susceptibility
Obesity
Genetic Predisposition to Disease
Disease Attributes
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 09, 2014