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Sponsors and Collaborators: |
Pennington Biomedical Research Center National Institutes of Health (NIH) |
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Information provided by: | Pennington Biomedical Research Center |
ClinicalTrials.gov Identifier: | NCT00412269 |
The purpose of this study is to determine the effect of menopause on obesity, energy balance, and insulin in postmenopausal, obese women.
Condition |
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Menopause |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Healthy Transitions: Menopause Effect on Obesity, Energy Balance, and Insulin |
Enrollment: | 160 |
Study Start Date: | February 1998 |
Study Completion Date: | March 2007 |
Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
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:
Ages Eligible for Study: | 47 Years to 52 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Pennington Biomedical Research Center is located in Baton Rouge, Louisiana, adjacent to the medical services district of the Regional Medical Center. The city of Baton Rouge is the home of state government, the 27,000-student Louisiana State University, the 9,000-student Southern University and a large petrochemical industry. Lacking the traditional active urban "downtown", the region is characterized by the suburban pattern of single family subdivisions and small apartment complexes. The population within a 7 parish (i.e. county) area is 635,202. The population of East Baton Rouge Parish is 380,105 with an ethnic distribution of 62% Caucasian, 35% African-American, 1% Asian, and <1% Native American and Hispanic. There are 34,885 people over age 65 and 251,586 between ages 16-65 yr.
Inclusion Criteria:
Exclusion Criteria:
United States, Louisiana | |
Pennington Biomedical Research Center | |
Baton Rouge, Louisiana, United States, 70808 |
Principal Investigator: | Steven R Smith, M. D. | Pennington Biomedical Research Center |
Responsible Party: | Pennigton Biomedical Research Center ( Steven R Smith ) |
Study ID Numbers: | PBRC97022 |
Study First Received: | December 14, 2006 |
Last Updated: | February 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00412269 |
Health Authority: | United States: Institutional Review Board |
Insulin Sensitivity Total abdominal fat Visceral abdominal fat Reproductive Hormones |
Menopause Diabetes Fat Distribution Sex Hormones |
Obesity Diabetes Mellitus Healthy Insulin Menopause |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |