Longitudinal Study of the Menopause and Fat Patterning

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Lynda Powell, PhD, MEd, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT00035659
First received: May 4, 2002
Last updated: October 19, 2012
Last verified: October 2012
  Purpose

To study the natural history of the accumulation of intra-abdominal fat as women progress through the menopause.


Condition
Cardiovascular Diseases
Menopause
Heart Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Enrollment: 868
Study Start Date: April 2002
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Detailed Description:

BACKGROUND:

Menopause alters the risk for a variety of chronic diseases, including cardiovascular disease, which is the number one cause of mortality in older women. While the associations between menopause, increased total and intra-abdominal fat (IAF), and risk for coronary disease are well established, prospective studies describing the accumulation of IAF, the association with risk factors, and potential mechanistic aspects, are still lacking. This study has the potential to provide important information on the trajectory of IAF accumulation across the menopausal transition in minority and non-minority women.

DESIGN NARRATIVE:

The prospective study will be conducted on an intact biracial cohort of 868 women (419 African Americans; 449 Caucasians) who are participating in a larger study (Women in the Southside Health [WISH] Project) of women undergoing the menopausal transition. This is a population-based cohort that was randomly selected from an existing census with a 72 percent participation rate, approximately equal distribution of socioeconomic status within the African American and Caucasian subgroups, and a dropout rate of only 1 percent/year. As part of the larger study, this cohort undergoes annual exams in which a variety of cardiovascular, hormonal, and lifestyle factors are tracked. These annual measurements consisting of a large number of relevant covariates, including demographics, anthropometrics, serum lipids, blood pressures, insulin, glucose, hormones, lifestyle, health and psychosocial status will be available from the parent study. For this study, two additional clinical tests will be added to the battery at the fourth or fifth annual exam for the 536 women who are expected to be eligible by virtue of not having had a hysterectomy or begun taking hormone therapy. The two tests will be a computed tomography scan for the assessment of intra-abdominal fat, and a dual energy X-ray absorptiometry (DEXA) scan for the assessment of total body fat. These tests will be repeated on an annual basis for the next three years. By the end of the study, it is projected that 462 transitions in menopausal status will have taken place. Random effects models will be used to estimate longitudinal changes in level and rate of intra-abdominal fat as one moves from one menopausal status to another.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The prospective study will be conducted on an intact biracial cohort of 868 women (419 African Americans; 449 Caucasians) who are participating in a larger study (Women in the Southside Health [WISH] Project) of women undergoing the menopausal transition.

Criteria

No eligibility criteria

  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: NCT00035659

Sponsors and Collaborators
Rush University Medical Center
Investigators
Principal Investigator: Lynda Powell, MD Rush University Medical Center
  More Information

No publications provided

Responsible Party: Lynda Powell, PhD, MEd, M.D., Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00035659     History of Changes
Other Study ID Numbers: 996, R01HL067128
Study First Received: May 4, 2002
Last Updated: October 19, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 16, 2014