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

Primary Purpose

Hyperandrogenism, Glucocorticoid Metabolism

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
lipid/heparin infusion
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperandrogenism focused on measuring androgens, fatty acids

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Charite, Campus Benjamin Franklin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

LHI

SHI

Arm Description

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

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

Outcomes

Primary Outcome Measures

change of DHEA
Measurement of serum DHEA
change of DHEAS
Measurement of serum DHEAS
change of testosterone
Measurement of serum testosterone
change of androstenedione
Measurement of serum androstenedione

Secondary Outcome Measures

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

Full Information

First Posted
May 14, 2007
Last Updated
January 23, 2018
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT00473603
Brief Title
Effect of Free Fatty Acids (FFA) on Androgen Precursors in Women
Official Title
Effect of Free Fatty Acids on Androgen Precursors in Vivo in Healthy Young Women
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperandrogenism, Glucocorticoid Metabolism
Keywords
androgens, fatty acids

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LHI
Arm Type
Experimental
Arm Description
to perform an i.v. lipid heparin infusion for 4 h
Arm Title
SHI
Arm Type
Sham Comparator
Arm Description
to perform an i.v. saline heparin infusion for 4 h
Intervention Type
Drug
Intervention Name(s)
lipid/heparin infusion
Intervention Description
to perform an i.v. lipid heparin infusion infusion for 4 h
Primary Outcome Measure Information:
Title
change of DHEA
Description
Measurement of serum DHEA
Time Frame
1 day
Title
change of DHEAS
Description
Measurement of serum DHEAS
Time Frame
1 day
Title
change of testosterone
Description
Measurement of serum testosterone
Time Frame
1 day
Title
change of androstenedione
Description
Measurement of serum androstenedione
Time Frame
1 day
Secondary Outcome Measure Information:
Title
urinary androgen excretion
Time Frame
1 day
Title
urinary cortisol excretion
Description
measurement of urinary cortisol, aTHF and THF
Time Frame
1 day
Title
urinary cortisone excretion
Description
measurement of urinary cortisone and THE
Time Frame
1 day
Title
changes in metabolic parameters (e.g. FGF-21)
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Knut Mai, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charite, Campus Benjamin Franklin
City
Berlin
Country
Germany

12. IPD Sharing Statement

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

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