A Cohort Research of Genetic Susceptibility for Common Obesity in Women

NCT01488903 | Unknown

• 1 other identifier: 2011-06-013GA
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Menopause

Keywords

genetic susceptibility; obesity; body composition; the metabolic syndrome; women

Outcome Measures

Primary Outcomes (1)

• genetic associations with body-mass index and waist circumference.

  genetic associations with body-mass index and waist circumference.

  3 years

Secondary Outcomes (2)

• genetic associations with body fat composition

  3 years

• genetic associations with the metabolic syndrome

  3 years

Study Arms (2)

Premenopausal Women

600 health premenopausal Women

Postmenopausal women

600 healthy postmenopausal women

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• National Yang Ming Chiao Tung University: collaborator

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 112, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

DNA, fasting blood samples

MeSH Terms

Conditions

Obesity; Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Susceptibility; Disease Attributes; Pathologic Processes

Study Officials

• Chii-Min Hwu, MD

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chii-Min Hwu, MD

CONTACT

886228757516; chhwu@vghtpe.gov.tw

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investgator

Study Record Dates

• First Submitted: December 6, 2011
• First Posted: December 8, 2011
• Study Start: September 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 14, 2011

Record last verified: 2011-12

Locations

TW (1)