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Acute Metabolic Effects of Estradiol

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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

Tracking Information
First Submitted Date  ICMJE February 13, 2007
First Posted Date  ICMJE February 14, 2007
Last Update Posted Date February 14, 2007
Study Start Date  ICMJE June 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2007)
  • Regional lipolysis assessed by microdialysis
  • Systemic lipolysis assessed by the isotope dilution technique
  • Lipoprotein lipase activity
  • Adrenergic receptor mRNA expression
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2007)
  • Estrogen receptor mRNA expression
  • UCP2 mRNA expression
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acute Metabolic Effects of Estradiol
Official Title  ICMJE Acute Effects of Estradiol on Lipolysis in Subcutaneous Adipose Tissue and Muscle Assessed by Microdialysis and Tissue Biopsies
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE Postmenopause
Intervention  ICMJE Drug: estradiol
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: February 13, 2007)
8
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE July 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Obesity (BMI>30)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00435175
Other Study ID Numbers  ICMJE 2002-0242
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lars C Gormsen, MD Aarhus University, Clinical Institute
PRS Account University of Aarhus
Verification Date February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP