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

NCT00005769 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2005-06-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Hormone Replacement Therapy

Sponsors & Collaborators

  • National Center for Research Resources (NCRR)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00005769 on ClinicalTrials.gov