HyperandrogenismNCT00473603
Effect of Free Fatty Acids (FFA) on Androgen Precursors in Women
A study testing lipid/heparin infusion in people with Hyperandrogenism and Glucocorticoid Metabolism, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether free fatty acids modify the androgen levels in healthy young women. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperandrogenism, Glucocorticoid Metabolism
- What is being tested?
- lipid/heparin infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2006to May 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy men and women
Who cannot join
- diabetes mellitus or impaired glucose tolerance
- clinical signs of hyperandrogenism
- polycystic ovary
- hormonal therapy
- BMI > 30 kg/m2
- dysmenorrhoea
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hyperandrogenism, Glucocorticoid Metabolism
- Being tested
- lipid/heparin infusion
- Keywords
- androgens, fatty acids
- Medical subject headings
- Hyperandrogenism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lipid/heparin infusionDrug
to perform an i.v. lipid heparin infusion infusion for 4 h
| Study group | Role | What they receive |
|---|---|---|
| LHI | Experimental | to perform an i.v. lipid heparin infusion for 4 h Receives: Drug: lipid/heparin infusion |
| SHI | Sham comparator | to perform an i.v. saline heparin infusion for 4 h Receives: Drug: lipid/heparin infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of DHEA
Measurement of serum DHEA
Measured: 1 day
change of DHEAS
Measurement of serum DHEAS
Measured: 1 day
change of testosterone
Measurement of serum testosterone
Measured: 1 day
change of androstenedione
Measurement of serum androstenedione
Measured: 1 day
Secondary outcomes (4)
urinary androgen excretion
Measured: 1 day
urinary cortisol excretion
measurement of urinary cortisol, aTHF and THF
Measured: 1 day
urinary cortisone excretion
measurement of urinary cortisone and THE
Measured: 1 day
changes in metabolic parameters (e.g. FGF-21)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2007 (estimated)
- Study startDec 2006
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperandrogenismStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Joachim Spranger, Charite University, Berlin, Germany
- Investigators
- Knut Mai, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00473603
- Sponsor's protocol ID
- 201-05
- Status last verified
- Jan 2018
- First submitted
- 14 May 2007
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Free Fatty Acids on Androgen Precursors in Vivo in Healthy Young Women
- ClinicalTrials.gov ID
- NCT00473603
- Acronym / sponsor ID
- 201-05
- Conditions
- Hyperandrogenism, Glucocorticoid Metabolism
- Keywords
- androgens, fatty acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 15 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LHI | Experimental | Drug: lipid/heparin infusionto perform an i.v. lipid heparin infusion for 4 h |
| SHI | Sham comparator | Drug: lipid/heparin infusionto perform an i.v. saline heparin infusion for 4 h |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy men and women
Key exclusion criteria (6 listed)
- diabetes mellitus or impaired glucose tolerance
- clinical signs of hyperandrogenism
- polycystic ovary
- hormonal therapy
- BMI > 30 kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lipid/heparin infusionto perform an i.v. lipid heparin infusion infusion for 4 h | Drug | LHI, SHI |
Primary outcome
change of DHEA
Time frame: 1 day
Measurement of serum DHEA
change of DHEAS
Time frame: 1 day
Measurement of serum DHEAS
change of testosterone
Time frame: 1 day
Measurement of serum testosterone
change of androstenedione
Time frame: 1 day
Measurement of serum androstenedione
4 secondary outcomes
urinary androgen excretion
Time frame: 1 day
urinary cortisol excretion
Time frame: 1 day
urinary cortisone excretion
Time frame: 1 day
changes in metabolic parameters (e.g. FGF-21)
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Knut Mai, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lipid/heparin infusion in people with Hyperandrogenism and Glucocorticoid Metabolism, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of DHEA (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.