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

Hyperandrogenism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00473603
• Other study ID #: 201-05
• Status: Completed
• Phase: N/A
• First received: May 14, 2007
• Last updated: January 23, 2018
• Start date: December 2006
• Est. completion date: May 2008

Study information

• Verified date: January 2018
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucocorticoid Metabolism
• Hyperandrogenism

Intervention

Drug:
• lipid/heparin infusion
to perform an i.v. lipid heparin infusion infusion for 4 h

Locations

Country	Name	City	State
Germany	Charite, Campus Benjamin Franklin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of DHEA	Measurement of serum DHEA	1 day
Primary	change of DHEAS	Measurement of serum DHEAS	1 day
Primary	change of testosterone	Measurement of serum testosterone	1 day
Primary	change of androstenedione	Measurement of serum androstenedione	1 day
Secondary	urinary androgen excretion		1 day
Secondary	urinary cortisol excretion	measurement of urinary cortisol, aTHF and THF	1 day
Secondary	urinary cortisone excretion	measurement of urinary cortisone and THE	1 day
Secondary	changes in metabolic parameters (e.g. FGF-21)		1 day