Longitudinal Study of the Menopause and Fat Patterning

June 15, 2023 updated by: Lynda Powell, PhD, MEd, Rush University Medical Center
To study the natural history of the accumulation of intra-abdominal fat as women progress through the menopause.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

868

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

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.

Description

Women eligible for this ancillary study had no history of diabetes, chronic liver disease or renal disease, no self-reported history of anorexia nervosa, no alcohol or drug abuse, were not currently pregnant or planning to become pregnant, and had not undergone hysterectomy and/or bilateral oophorectomy. Equipment limitations precluded participation of women with breast implants, hip replacements, or weighing ≥299 pounds.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rush University Medical Center

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Lynda Powell, MD, Rush University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

May 4, 2002

First Submitted That Met QC Criteria

May 4, 2002

First Posted (Estimated)

May 6, 2002

Study Record Updates

Last Update Posted (Estimated)

June 19, 2023

Last Update Submitted That Met QC Criteria

June 15, 2023

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 996
  • R01HL067128 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Diseases

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe