NCT00035659

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
868

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2002

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 4, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2002

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

June 18, 2023

Status Verified

October 1, 2015

Enrollment Period

5.9 years

First QC Date

May 4, 2002

Last Update Submit

June 15, 2023

Conditions

Cardiovascular DiseasesMenopauseHeart Diseases

Eligibility Criteria

Age42 Years - 61 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiovascular DiseasesHeart Diseases

Study Officials

  • Lynda Powell, MD

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

May 4, 2002

First Posted

May 6, 2002

Study Start

April 1, 2002

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

June 18, 2023

Record last verified: 2015-10