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
Recruitment status was Active, not recruiting
Sponsor:
National Center for Research Resources (NCRR)
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
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Menopause |
Drug: Hormone Replacement Therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by National Center for Research Resources (NCRR):
Eligibility| Ages Eligible for Study: | 45 Years to 55 Years (Adult) |
| Genders 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00005769
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | June 1, 2000 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 27, 2016