We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Acute Metabolic Effects of Estradiol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00435175
Recruitment Status : Completed
First Posted : February 14, 2007
Last Update Posted : February 14, 2007
Sponsor:
Information provided by:
University of Aarhus

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Estradiol promotes and maintains the typical female phenotype characterized by subcutaneous fat accumulation. There is evidence to suggest that this effect relies on the ability of estradiol to increase the amount of anti-lipolytic α2A-adrenergic receptors, but whether this requires long-term exposure to estradiol or is the result of an immediate effect is not clear. Objective: To study acute effects of a single dose (4 mg) of 17β-estradiol on regional and systemic lipolysis.

Condition or disease Intervention/treatment Phase
Postmenopause Drug: estradiol Not Applicable

Detailed Description:

Estradiol affects muscle and fat distribution, and thereby lipid metabolism. A reduction in muscle power is seen after menopause, readily counteracted by female hormone therapy (HT). Treatment with HT through months to previously untreated postmenopausal women, or hormone replacement therapy (HRT) to women with Turner syndrome, increases muscle mass and reduces fat mass. HT in postmenopausal women furthermore prevents fat accumulation and increases lipoprotein lipase activity and lipolysis to an extent comparable to premenopausal women. In contrast, it has also been shown that estradiol may actually attenuate lipolysis during basal as well as catecholamine stimulated conditions. In addition, one study found whole body fat metabolism to be lower during treatment with estradiol than without, and reduced lipolysis is present in postmenopausal women during treatment with estradiol, along with an increased number of α-adrenergic receptors and a decreased number of β-adrenergic receptors.

It is not clear whether the lipolytic effect of estradiol happens acutely or is dependent on chronic exposure. Moreover, regional differences in the pharmacodynamics of estradiol have not been assessed. Finally, effects on skeletal muscle have never been examined.

The purpose of the present study was 1) by microdialysis to quantify the regional production of glycerol in two tissues (muscle and fat), and in two regions (abdominal and femoral). 2) To quantify the whole-body lipolytic effect of estradiol, and 3) in biopsies to study intracellular mechanisms behind the action of estradiol.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Acute Effects of Estradiol on Lipolysis in Subcutaneous Adipose Tissue and Muscle Assessed by Microdialysis and Tissue Biopsies
Study Start Date : June 2005
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Regional lipolysis assessed by microdialysis
  2. Systemic lipolysis assessed by the isotope dilution technique
  3. Lipoprotein lipase activity
  4. Adrenergic receptor mRNA expression

Secondary Outcome Measures :
  1. Estrogen receptor mRNA expression
  2. UCP2 mRNA expression

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Postmenopausal women assessed by FSH and estradiol levels
  • Not taking any drugs
  • Non-smokers

Exclusion Criteria:

  • Obesity (BMI>30)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00435175


Locations
Layout table for location information
Denmark
Medical Research Laboratories
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Layout table for investigator information
Principal Investigator: Lars C Gormsen, MD Aarhus University, Clinical Institute
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00435175    
Other Study ID Numbers: 2002-0242
First Posted: February 14, 2007    Key Record Dates
Last Update Posted: February 14, 2007
Last Verified: February 2007
Keywords provided by University of Aarhus:
Estradiol
Lipolysis
Estrogen receptor
 Adrenergic receptors
UCP2
Postmenopausal women
Additional relevant MeSH terms:
Layout table for MeSH terms
Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs