PCOS DiseaseSEANCT03573063
Studying the Starvation Effect on Androgen Metabolism in 20 Healthy Young Women and Comparison to Women With PCOS.
A study testing Androgen metabolism after starvation in people with PCOS Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
In this study, the investigators wanted to investigate the energy homeostasis and the steroid metabolism of 20 healthy, young and normal weight women aged between 16-35 years before and after a 48 hours fasting period. Read more about this study
- Who is it for?
- Ages 16 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PCOS Disease
- What is being tested?
- Androgen metabolism after starvation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 26 Oct 2018to 30 Jun 2019
- 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 16 to 35 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Aged 16-35
- Normal weight
- Healthy
- Postpubertal
- No drug treatments (including oral/hormonal anticonception)
- Informed consent
Who cannot join
- Hormone treatment (i.e.: hormonal contraception, cortisol)
- Hormone disorders
- Infertile
- Anorexic
- Obese
- Pregnant
- Chronic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Starvation Effect on Androgen Metabolism in Healthy Young Women.
In this study, the investigators wanted to investigate the energy homeostasis and the steroid metabolism of 20 healthy, young and normal weight women aged between 16-35 years before and after a 48 hours fasting period.
The following substrates and hormone concentrations representing the carbohydrate, fat and protein metabolism will be measured from plasma or urine before and after fasting: glucose, insulin, lactate, alpha-synucleine, free fatty acids, beta-hydroxybutyrate (ketone bodies), carnitine (surrogate for acetyl-CoA) and alanine (amino acids). In addition, the investigators will measure 67 steroid metabolites by GC/MS and Biokrates AbsolutIDQ Steroid Assay in all collected urines and blood samples.
In the analysis of the data, the investigators will focus on correlations between biochemical parameters of the energy metabolism and parameters of the steroid metabolism, specifically the androgens. In addition, the steroid profiles obtained from healthy young women before and after fasting will be compared to steroid profiles of PCOS women in search for specific differences.
Read the detailed description
The first aim of this study is to investigate the energy homeostasis and the steroid metabolism of healthy, young and normal weight women aged 16-35 years, before and after a 48 hours fasting period. Furthermore, second aim of this study is the comparison of their steroid profiles with PCOS women in search for specific differences.
In fact it might be therefore hypothesized that the energy metabolism in PCOS women functions like under (glucose) starvation conditions. In a pilot experiment performed in a healthy young women of normal weight, the investigators observed that short term starvation over 48 hours changed her steroid profile from normal to PCOS-like with elevated testosterone with elevated testosterone, DHT and androsterone/etiocholanolone ratio. It has been suggested that during normal fasting and feeding metabolic signals such as AMP/NAD+ and acetyl-CoA translate the energy state into specific metabolic programs. The investigators suggest that androgen biosynthesis might be one of these programs. Therefore, becoming hyperandrogenic during short term starvation might be normal, and the regulation between energy balance and androgen biosynthesis might be visible in healthy subjects, thereby hinting pathways leading to PCOS and better treatment options.
In this study the investigators will recruit 20 healthy, normal weight women aged 16-35 years with regular cycle and without drug treatment, including hormonal contraception. Characteristics of the participant and written informed consent with the study will be collected. The study will start 14-21 days after the last menstrual period of the participant. Twenty-four hours prior the first study visit the participant will collect a 24 hours urine sample and a spot urine.
On day one of the study, the participant will come early morning for the first visit to the Inselspital Bern. The participant will be informed again and the exact study protocol will be explained to make sure the participant is willing to fulfil the study requirements. The investigators will draw blood, perform a pregnancy test and collect the 24 hours urine as well as a spot urine. At this point the starvation period will start (=intake to a maximum of 500-800 kcal/d for 24 hours, depends on the weight of the participant). A dietary plan is provided by Mrs. T. Zürcher, Pediatric Dietician, Childrens' Hosp. Inselspital Berne.
This regimen is selected on the basis that the human body switches into a state of "hunger" and starts to burn fat instead of glucose after about 12 hours. During a 48 hours fasting period the metabolism changes dramatically. During this state hormonal and chemical changes will be investigated in blood and urine samples. During the starvation the participants have to stick strictly to the dietary restriction regimen, which they will monitor themselves. If the participants fails to do so, they will be excluded from continuation of the study and cannot participate a second time. Fasting state and thus compliance are visible in the measured lab data (e.g. ketone bodies).
Two blood samples and two 24 hours urine samples and spot urines will be collected after 24 and 48 hours in the morning. After the third visit the study is completed for the participant. The blood samples and urine samples will be stored at -20°C until the day of measurement. If agreed by the participant, data and samples will be used for future studies in the same research field.
The collected samples of the participant (three blood and three 24-hours urine samples) will be analysed for metabolic markers (glucose, potassium, insulin, lactate, free fatty acids, ketone-bodies (beta-hydroxy-butyrate), carnitin, alanin) and for a multitude of steroids (progesterons, androgens, estrogens, corticosterones, mineralocorticoids, glucocorticoids). The measurements will be conducted according to GLP-standards. All laboratory parameters will be analysed in the University Hospital of Berne (Inselspital) in the laboratories of the Institute of Clinical Chemistry and Steroid Laboratory of Nephrology.
The obtained data will be entered in an existing RedCap database established for PCOS research of the PI. Laboratory data will be statistically analysed and compared to previous data obtained from a currently closing PCOS study being analysed.
- Conditions
- PCOS Disease
- Being tested
- Androgen metabolism after starvation
- Keywords
- starvation, androgens, healthy women, PCOS
- Medical subject headings
- Starvation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Androgen metabolism after starvationOther
The 20 women will all undergo the same process of starvation for 48 hours. During this time three blood samples and three 24-hours urine samples will be collected. At baseline, the investigators will draw blood, perform a pregnancy test and collect the 24 hours urine as well as a spot urine.
Then the 48 hours starvation starts and two blood and two 24 hours urine samples and spot urines will be collected after 24 and 48 hours in the morning. After the third visit the study is completed for the participant.
| Study group | Role | What they receive |
|---|---|---|
| Androgen metabolism after starvation | Other | Metabolism changes after 48 hours starvation in healthy women Receives: Other: Androgen metabolism after starvation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is changes in androgen metabolism. The evaluation will compare the steroid concentrations at the three time points with uni- and multivariate data analysis to detect fasting-related differences.
With GC/MS (urine) and LCMSMS (blood) 40 steroids in urine (ug/24h) and 18 steroids in serum (pg/ml or nmol/L) (Biokrates) will be measured; these includes Progesterones, Androgens, Estrogens, Corticosterones, Mineralocorticoids, Glucocorticoids. Other markers consist of glucose (mmol/L), potassium (mmol/L), insulin (mU/L), lactate (mmol/L), free fatty acids (umol/L), ketone-bodies (beta-hydroxy-butyrate), carnitin, alanin - all umol/L). All parameters will be analysed in the laboratories of the Institute of Clinical Chemistry and Steroid Laboratory of Nephrology of Inselspital. For more details please see list in Appendices of the Clinical Study Protocol (Page 38-41). All data are assessed as absolute values and follow-up is studied for changes in values rather than for normative values, which mostly do not exist for fasting intervention.
Measured: One year
Secondary outcomes (1)
Steroid profiles
Working hypothesis: Starvation may change steroid profiles in similar direction as PCOS? - To test this hypothesis the collected biological samples of the participant will be analysed for steroid metabolic markers (see primary outcome measures) to same markers collected from a cohort of PCOS women available from a previous study for comparison.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start26 Oct 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOS DiseaseStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Clinical study with biological sampling in healthy young women being nutrionally restricted (using encoded data)
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christa Flück, Principal investigator, Pädiatrische Endokrinologie, Inselspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573063
- Sponsor's protocol ID
- 2017-00982
- Other IDs
- 2017
- Acronym
- SEA
- Status last verified
- Sep 2019
- First submitted
- 2 Mar 2018
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Starvation Effect on Androgen Metabolism in Healthy Young Women.
- ClinicalTrials.gov ID
- NCT03573063
- Acronym / sponsor ID
- SEA / 2017-00982
- Conditions
- PCOS Disease
- Keywords
- starvation, androgens, healthy women, PCOS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 26 Oct 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 29 Jun 2018 (actual)
- 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.
In this study, the investigators wanted to investigate the energy homeostasis and the steroid metabolism of 20 healthy, young and normal weight women aged between 16-35 years before and after a 48 hours fasting period.
The following substrates and hormone concentrations representing the carbohydrate, fat and protein metabolism will be measured from plasma or urine before and after fasting: glucose, insulin, lactate, alpha-synucleine, free fatty acids, beta-hydroxybutyrate (ketone bodies), carnitine (surrogate for acetyl-CoA) and alanine (amino acids). In addition, the investigators will measure 67 steroid metabolites by GC/MS and Biokrates AbsolutIDQ Steroid Assay in all collected urines and blood samples.
In the analysis of the data, the investigators will focus on correlations between biochemical parameters of the energy metabolism and parameters of the steroid metabolism, specifically the androgens. In addition, the steroid profiles obtained from healthy young women before and after fasting will be compared to steroid profiles of PCOS women in search for specific differences.
Detailed description
The first aim of this study is to investigate the energy homeostasis and the steroid metabolism of healthy, young and normal weight women aged 16-35 years, before and after a 48 hours fasting period. Furthermore, second aim of this study is the comparison of their steroid profiles with PCOS women in search for specific differences.
In fact it might be therefore hypothesized that the energy metabolism in PCOS women functions like under (glucose) starvation conditions. In a pilot experiment performed in a healthy young women of normal weight, the investigators observed that short term starvation over 48 hours changed her steroid profile from normal to PCOS-like with elevated testosterone with elevated testosterone, DHT and androsterone/etiocholanolone ratio. It has been suggested that during normal fasting and feeding metabolic signals such as AMP/NAD+ and acetyl-CoA translate the energy state into specific metabolic programs. The investigators suggest that androgen biosynthesis might be one of these programs. Therefore, becoming hyperandrogenic during short term starvation might be normal, and the regulation between energy balance and androgen biosynthesis might be visible in healthy subjects, thereby hinting pathways leading to PCOS and better treatment options.
In this study the investigators will recruit 20 healthy, normal weight women aged 16-35 years with regular cycle and without drug treatment, including hormonal contraception. Characteristics of the participant and written informed consent with the study will be collected. The study will start 14-21 days after the last menstrual period of the participant. Twenty-four hours prior the first study visit the participant will collect a 24 hours urine sample and a spot urine.
On day one of the study, the participant will come early morning for the first visit to the Inselspital Bern. The participant will be informed again and the exact study protocol will be explained to make sure the participant is willing to fulfil the study requirements. The investigators will draw blood, perform a pregnancy test and collect the 24 hours urine as well as a spot urine. At this point the starvation period will start (=intake to a maximum of 500-800 kcal/d for 24 hours, depends on the weight of the participant). A dietary plan is provided by Mrs. T. Zürcher, Pediatric Dietician, Childrens' Hosp. Inselspital Berne.
This regimen is selected on the basis that the human body switches into a state of "hunger" and starts to burn fat instead of glucose after about 12 hours. During a 48 hours fasting period the metabolism changes dramatically. During this state hormonal and chemical changes will be investigated in blood and urine samples. During the starvation the participants have to stick strictly to the dietary restriction regimen, which they will monitor themselves. If the participants fails to do so, they will be excluded from continuation of the study and cannot participate a second time. Fasting state and thus compliance are visible in the measured lab data (e.g. ketone bodies).
Two blood samples and two 24 hours urine samples and spot urines will be collected after 24 and 48 hours in the morning. After the third visit the study is completed for the participant. The blood samples and urine samples will be stored at -20°C until the day of measurement. If agreed by the participant, data and samples will be used for future studies in the same research field.
The collected samples of the participant (three blood and three 24-hours urine samples) will be analysed for metabolic markers (glucose, potassium, insulin, lactate, free fatty acids, ketone-bodies (beta-hydroxy-butyrate), carnitin, alanin) and for a multitude of steroids (progesterons, androgens, estrogens, corticosterones, mineralocorticoids, glucocorticoids). The measurements will be conducted according to GLP-standards. All laboratory parameters will be analysed in the University Hospital of Berne (Inselspital) in the laboratories of the Institute of Clinical Chemistry and Steroid Laboratory of Nephrology.
The obtained data will be entered in an existing RedCap database established for PCOS research of the PI. Laboratory data will be statistically analysed and compared to previous data obtained from a currently closing PCOS study being analysed.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Clinical study with biological sampling in healthy young women being nutrionally restricted (using encoded data)
| Arm | Type | Receives |
|---|---|---|
| Androgen metabolism after starvation | Other | Other: Androgen metabolism after starvationMetabolism changes after 48 hours starvation in healthy women |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Aged 16-35
- Normal weight
- Healthy
- Postpubertal
- No drug treatments (including oral/hormonal anticonception)
Key exclusion criteria (7 listed)
- Hormone treatment (i.e.: hormonal contraception, cortisol)
- Hormone disorders
- Infertile
- Anorexic
- Obese
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 |
|---|---|---|
| Androgen metabolism after starvationThe 20 women will all undergo the same process of starvation for 48 hours. During this time three blood samples and three 24-hours urine samples will be collected. At baseline, the investigators will draw blood, perform a pregnancy test and collect the 24 hours urine as well as a spot urine. Then the 48 hours starvation starts and two blood and two 24 hours urine samples and spot urines will be collected after 24 and 48 hours in the morning. After the third visit the study is completed for the participant. | Other | Androgen metabolism after starvation |
Primary outcome
The primary outcome is changes in androgen metabolism. The evaluation will compare the steroid concentrations at the three time points with uni- and multivariate data analysis to detect fasting-related differences.
Time frame: One year
With GC/MS (urine) and LCMSMS (blood) 40 steroids in urine (ug/24h) and 18 steroids in serum (pg/ml or nmol/L) (Biokrates) will be measured; these includes Progesterones, Androgens, Estrogens, Corticosterones, Mineralocorticoids, Glucocorticoids. Other markers consist of glucose (mmol/L), potassium (mmol/L), insulin (mU/L), lactate (mmol/L), free fatty acids (umol/L), ketone-bodies (beta-hydroxy-butyrate), carnitin, alanin - all umol/L). All parameters will be analysed in the laboratories of the Institute of Clinical Chemistry and Steroid Laboratory of Nephrology of Inselspital. For more details please see list in Appendices of the Clinical Study Protocol (Page 38-41). All data are assessed as absolute values and follow-up is studied for changes in values rather than for normative values, which mostly do not exist for fasting intervention.
1 secondary outcome
Steroid profiles
Time frame: One year
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 6 Sep 2019.
Related trials for PCOS Disease
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
Active, not recruiting
Mindfulness-Based Education For Women With Polycystic Ovary Syndrome
Polycystic Ovary Syndrome (PCOS), Menstrual Symptoms
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.
Christa Flück principal investigator
Pädiatrische Endokrinologie, Inselspital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Androgen metabolism after starvation in people with PCOS Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 6 inclusion and 7 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 6 Sep 2019. 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 Switzerland. 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. 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?
The primary outcome is changes in androgen metabolism. The evaluation will compare the steroid concentrations at the three time points with uni- and multivariate data analysis to detect fasting-related differences. (time frame: One year). 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 6 Sep 2019.