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临床试验/NCT00412269
NCT00412269已完成不适用

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

Pennington Biomedical Research Center1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 1998年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
160
试验地点
1

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
47 Years 至 52 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Donna H. Ryan, MD

Professor, Adjunct

Pennington Biomedical Research Center

研究点 (1)

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