Postmenopause Clinical Trial
Official title:
Modulation of Visceral Fat by Estrogens After Menopause
The purpose of this study is to determine whether estrogens specifically promote a reduction in fat from abdominal regions during weight loss and/or prevent the accumulation of abdominal fat during weight gain.
The general aim of this study is to determine whether estrogen-based hormone therapy (HT) in
postmenopausal women reduces the accumulation of abdominal visceral fat and whether this is
a contributing factor to the effects of estrogens on cardiovascular risk factors. An
additional aim is to determine whether raloxifene, a selective estrogen receptor modulator
(SERM) that is suggested to be a safer alternative to estrogen for the prevention of
osteoporosis, exerts similar effects as estrogen on fat distribution. Mechanisms for
possible regional differences in the regulation of fat metabolism in estrogen-sufficient vs
estrogen-deficient states will be investigated, as will the extent to which estrogen status
and changes in visceral adiposity are associated with changes in risk for coronary artery
disease (CAD) and Type 2 diabetes mellitus (DM).
The hypotheses being tested include 1) reductions in total fat mass and total abdominal and
visceral fat will be significantly greater in women treated with HT or raloxifene than in
those receiving placebo treatment, 2) the accumulation of total fat mass and total abdominal
and visceral fat during the 12-month follow-up period will be significantly less in women on
HT or raloxifene than in those receiving placebo treatment, 3) a reduction in visceral fat
mass will be associated with increased sensitivity to insulin in the breakdown of fat in the
whole body, and there will be an independent enhancing effect of HT and raloxifene on
insulin action, and 4) changes in risk factors for CAD and Type 2 DM will be more closely
associated with changes in visceral adiposity than with changes in total fat mass or other
measures of regional adiposity, independent of and in addition to the effects of HT and
raloxifene on risk factors.
To meet these aims, a reduction in visceral fat will be induced in 108 postmenopausal women
through a 6-month program of supervised exercise training plus mild caloric restriction.
Participants will be randomized to receive HT, raloxifene, or placebo. The drug treatment
will continue, but the fat reduction program will cease, during a 12-month follow-up period.
Risk factors for CAD and Type 2 DM and insulin sensitivity in terms of the breakdown of fat
on total body and regional adipose tissue will be evaluated before and after treatment and
after the follow-up period (risk factors only). For the purpose of this application, HT
refers to a regimen involving daily conjugated estrogens and, in women with a uterus,
tri-monthly progestin treatment.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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