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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00412269
First Posted: December 18, 2006
Last Update Posted: January 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Donna H. Ryan, MD, Pennington Biomedical Research Center
  Purpose
The purpose of this study is to determine the effect of menopause on obesity, energy balance, and insulin in postmenopausal, obese women.

Condition
Menopause

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Healthy Transitions: Menopause Effect on Obesity, Energy Balance, and Insulin

Resource links provided by NLM:


Further study details as provided by Donna H. Ryan, MD, Pennington Biomedical Research Center:

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)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   47 Years to 52 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
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.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00412269


Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
National Institutes of Health (NIH)
Investigators
Principal Investigator: Steven R Smith, M. D. Pennington Biomedical Research Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Donna H. Ryan, MD, Professor, Adjunct, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT00412269     History of Changes
Other Study ID Numbers: PBRC 97022
First Submitted: December 14, 2006
First Posted: December 18, 2006
Last Update Posted: January 25, 2016
Last Verified: January 2016

Keywords provided by Donna H. Ryan, MD, Pennington Biomedical Research Center:
Insulin Sensitivity
Total abdominal fat
Visceral abdominal fat
Reproductive Hormones
Menopause
Diabetes
Fat Distribution
Sex Hormones

Additional relevant MeSH terms:
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs