Effect of Free Fatty Acids (FFA) on Androgen Precursors in Women - Full Text View

Sponsored by:	Charite University, Berlin, Germany
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT00473603

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

MedlinePlus related topics: Blood Thinners

Drug Information available for: Sodium chloride Heparin Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Effect of Free Fatty Acids on Androgen Precursors in Vivo in Healthy Young Women

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

Unaffiliated

More Information

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

Keywords provided by Charite University, Berlin, Germany:

androgens
fatty acids

Study placed in the following topic categories:

Gonadal Disorders
Endocrine System Diseases
Hyperandrogenism
Endocrinopathy

Healthy
Heparin
Sex Differentiation Disorders
Calcium heparin

Additional relevant MeSH terms:

Fibrin Modulating Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Hematologic Agents
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009