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

Not Applicable

Completed

• Conditions: Hyperandrogenism; Glucocorticoid Metabolism
• Interventions: Drug: lipid/heparin infusion

• Registration Number: NCT00473603
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

The purpose of this study is to determine whether free fatty acids modify the androgen levels in healthy young women.

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.

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-05-14
• Study First Submitted QC: 2007-05-14
• Study First Posted: 2007-05-15
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SHI	lipid/heparin infusion	to perform an i.v. saline heparin infusion for 4 h
LHI	lipid/heparin infusion	to perform an i.v. lipid heparin infusion for 4 h

Primary Outcome Measures

Name	Time	Method
change of DHEAS	1 day	Measurement of serum DHEAS
change of testosterone	1 day	Measurement of serum testosterone
change of androstenedione	1 day	Measurement of serum androstenedione
change of DHEA	1 day	Measurement of serum DHEA

Secondary Outcome Measures

Name	Time	Method
urinary androgen excretion	1 day
urinary cortisol excretion	1 day	measurement of urinary cortisol, aTHF and THF
changes in metabolic parameters (e.g. FGF-21)	1 day
urinary cortisone excretion	1 day	measurement of urinary cortisone and THE

Trial Locations

Locations (1)

Charite, Campus Benjamin Franklin; 🇩🇪 Berlin, Germany