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

January 22, 2016 updated by: Donna H. Ryan, MD, Pennington Biomedical Research Center
The purpose of this study is to determine the effect of menopause on obesity, energy balance, and insulin in postmenopausal, obese women.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

47 years to 52 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pennington Biomedical Research Center

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Steven R Smith, M. D., Pennington Biomedical Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 1998

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

December 14, 2006

First Submitted That Met QC Criteria

December 14, 2006

First Posted (Estimate)

December 18, 2006

Study Record Updates

Last Update Posted (Estimate)

January 25, 2016

Last Update Submitted That Met QC Criteria

January 22, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PBRC 97022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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