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Hormone Replacement Therapy and Insulin Action: A Double-Blind, Parallel, Placebo-Controlled Hormone Intervention Study in Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT00005769
Recruitment Status : Unknown
Verified November 2001 by National Center for Research Resources (NCRR).
Recruitment status was:  Active, not recruiting
First Posted : June 2, 2000
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
National Center for Research Resources (NCRR)

Study Description
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Brief Summary:
Considerable controversy exists regarding the effect of estrogen and progesterone on insulin sensitivity in postmenopausal women. Thus, the goal is to examine the effect of estradiol and progestin on in vivo insulin sensitivity and pathways of intracellular glucose metabolism in postmenopausal women. This will be accomplished by examining the effects of unopposed estrogen (CEE) or combination estrogen and progestin (CEE/MPA) versus placebo therapy in 30 early menopausal women (defined from 6 months to 3 years post-cessation of menses). Women will be treated for 16 weeks and the outcome measures will be: 1) insulin sensitivity and glucose oxidation as determined by euglycemic clamp, 2) assessments of insulin sensitivity on muscle biopsy cultures with the primary endpoints being glucose uptake and glycogen accumulation/synthesis, 3) protein levels of insulin action cascade steps based on muscle biopsy Western blots.

Condition or disease Intervention/treatment Phase
Menopause Drug: Hormone Replacement Therapy Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   45 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 6 months to 3 years since cessation of menses
  • BMD 24-33
  • no surgically induced menopause
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005769


Locations
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United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
National Center for Research Resources (NCRR)
More Information
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ClinicalTrials.gov Identifier: NCT00005769     History of Changes
Other Study ID Numbers: NCRR-M01RR00109-0744
M01RR000109 ( U.S. NIH Grant/Contract )
First Posted: June 2, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: November 2001
Additional relevant MeSH terms:
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Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs