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Effect of Free Fatty Acids (FFA) on Androgen Precursors in Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00473603
First Posted: May 15, 2007
Last Update Posted: July 24, 2008
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.
Information provided by:
Charite University, Berlin, Germany
  Purpose
The purpose of this study is to determine whether free fatty acids modify the androgen levels in healthy young women.

Condition Intervention
Hyperandrogenism Glucocorticoid Metabolism Drug: lipid/heparin or saline/heparin infusion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Free Fatty Acids on Androgen Precursors in Vivo in Healthy Young Women

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • change in adrenal androgens [ Time Frame: 1 day ]

Secondary Outcome Measures:
  • urinary androgen excretion [ Time Frame: 1 day ]
  • glucocorticoid metabolism and urinary glucocorticoid excretion [ Time Frame: 1 day ]

Enrollment: 13
Study Start Date: December 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Detailed Description:

Free fatty acids (FFA) are known to play an important role by inducing insulin resistance and metabolic disturbances in obesity and type 2 diabetes. In addition, FFAs seems to have a stimulatory effect on adrenal androgen precursors in men. However, the effect of FFAs on androgen precursors and androgens in women is yet unknown.

Therefore the effect of increased FFAs on adrenal androgens and androgen precursors should be investigated in a randomized controlled cross-over trial.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy men and women

Exclusion Criteria:

  • diabetes mellitus or impaired glucose tolerance
  • clinical signs of hyperandrogenism
  • polycystic ovary
  • hormonal therapy
  • BMI > 30 kg/m2
  • dysmenorrhoea
  Contacts and Locations
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): NCT00473603


Locations
Germany
Charite, Campus Benjamin Franklin
Berlin, Germany
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Knut Mai, MD
  More Information

ClinicalTrials.gov Identifier: NCT00473603     History of Changes
Other Study ID Numbers: 201-05
First Submitted: May 14, 2007
First Posted: May 15, 2007
Last Update Posted: July 24, 2008
Last Verified: May 2007

Keywords provided by Charite University, Berlin, Germany:
androgens
fatty acids

Additional relevant MeSH terms:
Hyperandrogenism
46, XX Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Adrenogenital Syndrome
Congenital Abnormalities
Gonadal Disorders
Endocrine System Diseases
Heparin
Androgens
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs