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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT00412269
First received: December 14, 2006
Last updated: February 15, 2008
Last verified: February 2008
  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 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

Ages Eligible for Study:   47 Years to 52 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412269

Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
Principal Investigator: Steven R Smith, M. D. Pennington Biomedical Research Center
  More Information

No publications provided by Pennington Biomedical Research Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steven R Smith, Pennigton Biomedical Research Center
ClinicalTrials.gov Identifier: NCT00412269     History of Changes
Other Study ID Numbers: PBRC97022
Study First Received: December 14, 2006
Last Updated: February 15, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014