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Healthy Transitions: Menopause Effect on Obesity, Energy Balance, and Insulin

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ClinicalTrials.gov Identifier: NCT00412269
Recruitment Status : Completed
First Posted : December 18, 2006
Last Update Posted : January 25, 2016
Information provided by (Responsible Party):

December 14, 2006
December 18, 2006
January 25, 2016
February 1998
March 2007   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00412269 on ClinicalTrials.gov Archive Site
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Healthy Transitions: Menopause Effect on Obesity, Energy Balance, and Insulin
Healthy Transitions: Menopause Effect on Obesity, Energy Balance, and Insulin
The purpose of this study is to determine the effect of menopause on obesity, energy balance, and insulin in postmenopausal, obese women.

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.
Observational Model: Cohort
Time Perspective: Prospective
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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.
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Lovejoy JC, Champagne CM, de Jonge L, Xie H, Smith SR. Increased visceral fat and decreased energy expenditure during the menopausal transition. Int J Obes (Lond). 2008 Jun;32(6):949-58. doi: 10.1038/ijo.2008.25. Epub 2008 Mar 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
March 2007
March 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 47-52 yr, at time of enrollment
  • Body Mass Index 25-40
  • Normal oral glucose tolerance test by National Diabetes Data Group criteria
  • Premenopausal, defined by FSH levels <30mIU/ml and at least 5 menstrual periods in the last 6 months
  • Able to confirm ethnic heritage of past 2 generations in family

Exclusion Criteria:

  • hypertension or hypercholesterolemia requiring medication
  • regular use of medications that influence glucose tolerance
  • use of oral contraceptives within the past 6 months
  • history of myocardial infarction or significant coronary vascular disease or stroke
  • history of endocrine, kidney, or liver disease or malignancy
  • any psychopathology, including eating disorders, substance abuse, and major depression
  • unable to complete longitudinal study commitment, including anticipating moving out of the area within the next 5 years.
Sexes Eligible for Study: Female
47 Years to 52 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
PBRC 97022
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Donna H. Ryan, MD, Pennington Biomedical Research Center
Pennington Biomedical Research Center
National Institutes of Health (NIH)
Principal Investigator: Steven R Smith, M. D. Pennington Biomedical Research Center
Pennington Biomedical Research Center
January 2016