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

This study has been completed.
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00473603
First received: May 14, 2007
Last updated: July 23, 2008
Last verified: May 2007
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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:

Drug Information available for: Heparin
U.S. FDA Resources

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

Primary Outcome Measures:
  • change in adrenal androgens [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • urinary androgen excretion [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • glucocorticoid metabolism and urinary glucocorticoid excretion [ Time Frame: 1 day ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00473603

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

No publications provided

ClinicalTrials.gov Identifier: NCT00473603     History of Changes
Other Study ID Numbers: 201-05
Study First Received: May 14, 2007
Last Updated: July 23, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Androgens
Calcium heparin
Heparin
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 16, 2013