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

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00412269
• Other study ID #: PBRC 97022
• Status: Completed
• Phase: N/A
• First received: December 14, 2006
• Last updated: January 22, 2016
• Start date: February 1998
• Est. completion date: March 2007

Study information

• Verified date: January 2016
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine the effect of menopause on obesity, energy balance, and insulin in postmenopausal, obese women.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 47 Years to 52 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Menopause

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States,