Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-28 @ 8:08 PM
Study NCT ID:
NCT00412269
Status:
COMPLETED
Last Update Posted:
2016-01-25
First Post:
2006-12-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healthy Transitions: Menopause Effect on Obesity, Energy Balance, and Insulin
Sponsor:
Pennington Biomedical Research Center
Organization:
Study Overview
Official Title:
Healthy Transitions: Menopause Effect on Obesity, Energy Balance, and Insulin
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the effect of menopause on obesity, energy balance, and insulin in postmenopausal, obese women.
Detailed Description:
The effect of menopause on body composition and cardiovascular risk in healthy caucasian women has been the subject of much study. In contrast, there are few data available on menopause in African-American women. Since menopause is associated with potentially preventable health risks in women, this proposal is aimed at characterizing the perimenopausal period in terms of body fat, energy balance, and insulin action in both caucasian and African-American women.
The study will address 4 general hypotheses:
* Menopause increases both total and visceral abdominal fat
* Changes in body composition and body weight at menopause are mediated, at least in part by changes in 24-hour energy expenditure and/or food intake
* Menopause results in decreased insulin sensitivity that may predispose certain women to develop diabetes later in life
* African-American women may respond to the shifts in reproductive hormones at menopause differently than caucasian women.
The study will address 4 general hypotheses:
* Menopause increases both total and visceral abdominal fat
* Changes in body composition and body weight at menopause are mediated, at least in part by changes in 24-hour energy expenditure and/or food intake
* Menopause results in decreased insulin sensitivity that may predispose certain women to develop diabetes later in life
* African-American women may respond to the shifts in reproductive hormones at menopause differently than caucasian women.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: