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

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Completed
CT.gov ID
NCT00473603
Collaborator
(none)
13
Enrollment
1
Location
2
Arms
17
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: lipid/heparin infusion
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
13 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Free Fatty Acids on Androgen Precursors in Vivo in Healthy Young Women
Study Start Date :
Dec 1, 2006
Actual Primary Completion Date :
May 1, 2008
Actual Study Completion Date :
May 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: LHI

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

Drug: lipid/heparin infusion
to perform an i.v. lipid heparin infusion infusion for 4 h
Sham Comparator: SHI

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

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

Outcome Measures

Primary Outcome Measures

  1. change of DHEA [1 day]

    Measurement of serum DHEA

  2. change of DHEAS [1 day]

    Measurement of serum DHEAS

  3. change of testosterone [1 day]

    Measurement of serum testosterone

  4. change of androstenedione [1 day]

    Measurement of serum androstenedione

Secondary Outcome Measures

  1. urinary androgen excretion [1 day]

  2. urinary cortisol excretion [1 day]

    measurement of urinary cortisol, aTHF and THF

  3. urinary cortisone excretion [1 day]

    measurement of urinary cortisone and THE

  4. changes in metabolic parameters (e.g. FGF-21) [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Charite, Campus Benjamin Franklin Berlin Germany

Sponsors and Collaborators

  • Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Knut Mai, MD,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Professor Joachim Spranger, professor, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00473603
Other Study ID Numbers:
  • 201-05
First Posted:
May 15, 2007
Last Update Posted:
Jan 25, 2018
Last Verified:
Jan 1, 2018
Keywords provided by Professor Joachim Spranger, professor, Charite University, Berlin, Germany
androgens
fatty acids
Additional relevant MeSH terms:
Hyperandrogenism
Heparin

Study Results

No Results Posted as of Jan 25, 2018