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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2001 by National Center for Research Resources (NCRR).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00005769
First received: June 1, 2000
Last updated: June 23, 2005
Last verified: November 2001

June 1, 2000
June 23, 2005
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Complete list of historical versions of study NCT00005769 on ClinicalTrials.gov Archive Site
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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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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.

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Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Menopause
Drug: Hormone Replacement Therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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Inclusion Criteria:

  • 6 months to 3 years since cessation of menses
  • BMD 24-33
  • no surgically induced menopause
Female
45 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005769
NCRR-M01RR00109-0744, M01RR00109
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National Center for Research Resources (NCRR)
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National Center for Research Resources (NCRR)
November 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP