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Acute Metabolic Effects of Estradiol
This study has been completed.
Sponsored by: University of Aarhus
Information provided by: University of Aarhus
ClinicalTrials.gov Identifier: NCT00435175
  Purpose

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 Intervention
Postmenopause
Drug: estradiol

Drug Information available for: Estradiol Estradiol 3-benzoate Polyestradiol phosphate Depogen Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Placebo Control, Crossover Assignment, Pharmacodynamics Study
Official Title: Acute Effects of Estradiol on Lipolysis in Subcutaneous Adipose Tissue and Muscle Assessed by Microdialysis and Tissue Biopsies

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Regional lipolysis assessed by microdialysis
  • Systemic lipolysis assessed by the isotope dilution technique
  • Lipoprotein lipase activity
  • Adrenergic receptor mRNA expression

Secondary Outcome Measures:
  • Estrogen receptor mRNA expression
  • UCP2 mRNA expression

Estimated Enrollment: 8
Study Start Date: June 2005
Estimated Study Completion Date: July 2006
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.

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00435175

Locations
Denmark
Medical Research Laboratories
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Lars C Gormsen, MD Aarhus University, Clinical Institute
  More Information

No publications provided

Study ID Numbers: 2002-0242
Study First Received: February 13, 2007
Last Updated: February 13, 2007
ClinicalTrials.gov Identifier: NCT00435175  
Health Authority: Denmark: Ethics Committee

Keywords provided by University of Aarhus:
Estradiol
Lipolysis
Estrogen receptor
Adrenergic receptors
UCP2
Postmenopausal women

Study placed in the following topic categories:
Benzoates
Estradiol 3-benzoate
Estradiol valerate
Estradiol 17 beta-cypionate
Polyestradiol phosphate
Estradiol

Additional relevant MeSH terms:
Estrogens
Contraceptive Agents
Therapeutic Uses
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2009