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Clinical Trials/NCT00005769
NCT00005769UnknownPhase 2

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

National Center for Research Resources (NCRR)1 site in 1 countryStarted: June 2, 2000Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Sponsor
Locations
1

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
45 Years to 55 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •6 months to 3 years since cessation of menses
  • •BMD 24-33
  • •no surgically induced menopause

Exclusion Criteria

  • Not provided

Investigators

Sponsor
National Center for Research Resources (NCRR)
Sponsor Class
Nih

Study Sites (1)

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