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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:

Study Description
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

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

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U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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


Locations
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
National Center for Research Resources (NCRR)
More Information

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:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs