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

Effect of Free Fatty Acids on Androgen Precursors in Vivo in Healthy Young Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00473603
Enrollment
13
Registered
2007-05-15
Start date
2006-12-31
Completion date
2008-05-31
Last updated
2018-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glucocorticoid Metabolism, Hyperandrogenism

Keywords

androgens, fatty acids

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.

Interventions

DRUGlipid/heparin infusion

to perform an i.v. lipid heparin infusion infusion for 4 h

Sponsors

Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
change of androstenedione1 dayMeasurement of serum androstenedione
change of DHEA1 dayMeasurement of serum DHEA
change of DHEAS1 dayMeasurement of serum DHEAS
change of testosterone1 dayMeasurement of serum testosterone

Secondary

MeasureTime frameDescription
urinary androgen excretion1 day
urinary cortisol excretion1 daymeasurement of urinary cortisol, aTHF and THF
urinary cortisone excretion1 daymeasurement of urinary cortisone and THE
changes in metabolic parameters (e.g. FGF-21)1 day

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026