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Completed

NCT Number: NCT00473603

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

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

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Key information

Conditions

Hyperandrogenism 46, XX Disorders of Sex Development Adrenogenital Syndrome Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucocorticoid Metabolism Gonadal Disorders Male Urogenital Diseases Urogenital Abnormalities Urogenital Diseases

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charite, Campus Benjamin Franklin

Berlin, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lipid/heparin infusion

Drug

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

Primary outcomes

  1. change of DHEA

    Time frame: 1 day

    Measurement of serum DHEA

  2. change of DHEAS

    Time frame: 1 day

    Measurement of serum DHEAS

  3. change of testosterone

    Time frame: 1 day

    Measurement of serum testosterone

  4. change of androstenedione

    Time frame: 1 day

    Measurement of serum androstenedione

Secondary outcomes

  1. urinary androgen excretion

    Time frame: 1 day

  2. urinary cortisol excretion

    Time frame: 1 day

    measurement of urinary cortisol, aTHF and THF

  3. urinary cortisone excretion

    Time frame: 1 day

    measurement of urinary cortisone and THE

  4. changes in metabolic parameters (e.g. FGF-21)

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
May 15, 2007
Registry last updated
Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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