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Longitudinal Study of the Menopause and Fat Patterning - Article


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Clinical Trial: Longitudinal Study of the Menopause and Fat Patterning

This study is no longer recruiting patients.

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)

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

MedlinePlus related topics:  Heart Diseases;   Heart Diseases--Prevention;   Vascular Diseases

Study Type: Observational
Study Design: Natural History, Longitudinal

Further Study Details: 

Study start: April 2002;  Study completion: March 2007

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

Criteria

No eligibility criteria

Location Information

Study chairs or principal investigators

Lynda Powell,  Rush Cancer Institute at Rush University Medical Center   

More Information

Study ID Numbers:  996
Record last reviewed:  December 2004
Last Updated:  January 10, 2005
Record first received:  May 4, 2002
ClinicalTrials.gov Identifier:  NCT00035659
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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Page Updated: May 11, 2006
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