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

January 23, 2018 updated by: Professor Joachim Spranger, Charite University, Berlin, Germany

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Charite, Campus Benjamin Franklin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of DHEA
Time Frame: 1 day
Measurement of serum DHEA
1 day
change of DHEAS
Time Frame: 1 day
Measurement of serum DHEAS
1 day
change of testosterone
Time Frame: 1 day
Measurement of serum testosterone
1 day
change of androstenedione
Time Frame: 1 day
Measurement of serum androstenedione
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
urinary androgen excretion
Time Frame: 1 day
1 day
urinary cortisol excretion
Time Frame: 1 day
measurement of urinary cortisol, aTHF and THF
1 day
urinary cortisone excretion
Time Frame: 1 day
measurement of urinary cortisone and THE
1 day
changes in metabolic parameters (e.g. FGF-21)
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Knut Mai, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

May 14, 2007

First Submitted That Met QC Criteria

May 14, 2007

First Posted (Estimate)

May 15, 2007

Study Record Updates

Last Update Posted (Actual)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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