Effect of Free Fatty Acids (FFA) on Androgen Precursors i... | NCT00473603

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

NCT00473603

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Jan 25, 2018Actual

Enrollment

13Actual

Phase

Not Applicable

Conditions

Hyperandrogenism
Glucocorticoid Metabolism

Interventions

lipid/heparin infusion

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

May 2008Actual

Completion Date

May 2008Actual

First Submitted Date

May 14, 2007

First Submission Date that Met QC Criteria

May 14, 2007

First Posted Date

May 15, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2018

Last Update Posted Date

Jan 25, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Professor Joachim Spranger, professor, Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LHI	Experimental	to perform an i.v. lipid heparin infusion for 4 h	Drug: lipid/heparin infusion
SHI	Sham Comparator	to perform an i.v. saline heparin infusion for 4 h	Drug: lipid/heparin infusion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lipid/heparin infusion	Drug	to perform an i.v. lipid heparin infusion infusion for 4 h	LHI SHI

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
urinary androgen excretion		1 day
urinary cortisol excretion	measurement of urinary cortisol, aTHF and THF	1 day

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Knut Mai, MD		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charite, Campus Benjamin Franklin		Berlin			Germany

Condition Browse Module

MeSH Terms

ID	Term
D017588	Hyperandrogenism

Ancestor Terms

ID	Term
D058489	46, XX Disorders of Sex Development
D012734	Disorders of Sex Development
D014564	Urogenital Abnormalities
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008055	Lipids

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided