Hepassocin (Hepatocyte-derived Fibrinogen-related Protein 1)NCT04369248
Hepassocin Levels in Patients With Polycystic Ovary Syndrome
An observational study of Hepassocin (Hepatocyte-derived Fibrinogen-related Protein 1) and Polycystic Ovary Syndrome, run by Fatma ketenci gencer at 1 site in Turkey (Türkiye).
Trial summary
The investigators aimed to investigate hepassocin levels in patients with polycystic ovary syndrome (PCOS). There are 3 groups aged between 18 and 35 years as non-obese healthy women, non-obese women with PCOS, and obese women (BMI>30) with PCOS. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hepassocin (Hepatocyte-derived Fibrinogen-related Protein 1), Polycystic Ovary Syndrome, Obesity
- What is being tested?
- hepassocin
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jan 2020to 25 Mar 2020
- Phase
- Observational
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: A total of 60 patients with PCOS aged between 18 and 35 and age matched 30 healthy women with BMI < 30 were enrolled to the study.
Who may be able to join
- 60 patients with PCOS aged between 18 and 35 and age-matched 30 healthy women with BMI<30
Who cannot join
- Premature ovarian failure (FSH >30 mIU/mL), tumors secreting androgens, non-classical congenital adrenal hyperplasia, Cushing syndrome and irregular menses due to thyroid dysfunction (TSH >5 mIU/L ), hyperprolactinemia, more than twofold high transaminase levels (>70 U/L), patients with cigarette smoking, alcohol consumption, oral contraceptives use, medications that are affecting liver function test, insulin metabolism and lipid metabolism, patients with a history of chronic diseases such as diabetes mellitus, hypertension, chronic liver disease, chronic kidney disease, autoimmune disease, inflammatory disease, malignant disease, bleeding disorders, and thrombosis were also excluded. All the patients were beta-HCG, hepatitis B surface antigen, and hepatitis C antibody negative.
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Taksim Education and Research Hospital
Istanbul
About this study
The investigators aimed to investigate hepassocin levels in patients with polycystic ovary syndrome (PCOS). There are 3 groups aged between 18 and 35 years as non-obese healthy women, non-obese women with PCOS, and obese women (BMI>30) with PCOS.
Read the detailed description
Hepassocin, also known as Fibrinogen-like-protein or hepatocyte-derived fibrinogen-related protein 1, is a new marker for obesity and insulin resistance. In hepatic injury, it protects liver cells and promotes regeneration. High levels of hepassocin was shown to be independently associated with HOMA-IR and diabetes. Since insulin resistance is known to be seen in patients with PCOS, it may be expected that hepassocin levels may be higher in this group of patients.
- Conditions
- Hepassocin (Hepatocyte-derived Fibrinogen-related Protein 1), Polycystic Ovary Syndrome, Obesity, Insulin Resistance
- Being tested
- hepassocin
- Medical subject headings
- Polycystic Ovary Syndrome, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepassocinOther
hepassocin levels in polycystic ovary syndrome
| Study group | Role | What they receive |
|---|---|---|
| Control group | 30 healthy women with BMI < 30 between 18 and 35 years old Receives: Other: hepassocin | |
| Non-obese PCOS | 2003 Rotterdam ESHRE/ASRM PCOS Consensus Criteria were used to diagnose PCOS that fulfilled at least two of the followings: chronic oligo-anovulation, clinic or biochemical hyperandrogenism and presence of polycyctic ovary by ultrasound (Rotterdam). Oligo-anovulation is defined as periods lasting more than 35 days and/or amenorrhea. Clinic or biochemical hyperandrogenism is defined as the presence of acnes and/ or Ferriman-Galleway modified score >8 and/ or hyperandrogenemia defining the testosterone level > 0.6 ng/ml (2 nmol/l) and/or dehydroepiandrosterone level > 3 ng/ml (10.5 nmol/l). Polycyctic ovaries are defined as the presence of more than 12 follicules 2-9 mm in diameters or ovarian volume >10 cm3 under transvaginal or abdominal ultrasound. non-obese group are the women BMI < 30 between age of 18 and 35. Receives: Other: hepassocin | |
| Obese PCOS | Obese group are the women with BMI > 30 between age of 18 and 35. Receives: Other: hepassocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepassocin levels in patients with polycystic ovary syndrome
hepassocin levels should be increased in polycyctic ovary syndrome due to its relation with insulin resistance.
Measured: January 2020-March 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start3 Jan 2020
- Primary completion15 Mar 2020
- Study completion25 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepassocin (Hepatocyte-derived Fibrinogen-related Protein 1)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatma ketenci gencer
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Fatma ketenci gencer, Gaziosmanpasa Research and Education Hospital
- Investigators
- fatma ketenci gencer, Study director, Gaziosmanpasa Taksim Education and Research Hospitalsibel bektas, Study chair, Gaziosmanpasa Taksim Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369248
- Sponsor's protocol ID
- GaziosmanpasaTREH19
- Status last verified
- Apr 2020
- First submitted
- 26 Apr 2020
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepassocin Levels in Patients With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT04369248
- Acronym / sponsor ID
- GaziosmanpasaTREH19
- Conditions
- Hepassocin (Hepatocyte-derived Fibrinogen-related Protein 1), Polycystic Ovary Syndrome, Obesity, Insulin Resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Fatma ketenci gencerOther government
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 25 Mar 2020 (actual)
- First posted
- 30 Apr 2020 (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.
The investigators aimed to investigate hepassocin levels in patients with polycystic ovary syndrome (PCOS). There are 3 groups aged between 18 and 35 years as non-obese healthy women, non-obese women with PCOS, and obese women (BMI>30) with PCOS.
Detailed description
Hepassocin, also known as Fibrinogen-like-protein or hepatocyte-derived fibrinogen-related protein 1, is a new marker for obesity and insulin resistance. In hepatic injury, it protects liver cells and promotes regeneration. High levels of hepassocin was shown to be independently associated with HOMA-IR and diabetes. Since insulin resistance is known to be seen in patients with PCOS, it may be expected that hepassocin levels may be higher in this group of patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Other: hepassocin30 healthy women with BMI < 30 between 18 and 35 years old |
| Non-obese PCOS | – | Other: hepassocin2003 Rotterdam ESHRE/ASRM PCOS Consensus Criteria were used to diagnose PCOS that fulfilled at least two of the followings: chronic oligo-anovulation, clinic or biochemical hyperandrogenism and presence of polycyctic ovary by ultrasound (Rotterdam). Oligo-anovulation is defined as periods lasting more than 35 days and/or amenorrhea. Clinic or biochemical hyperandrogenism is defined as the presence of acnes and/ or Ferriman-Galleway modified score >8 and/ or hyperandrogenemia defining the testosterone level > 0.6 ng/ml (2 nmol/l) and/or dehydroepiandrosterone level > 3 ng/ml (10.5 nmol/l). Polycyctic ovaries are defined as the presence of more than 12 follicules 2-9 mm in diameters or ovarian volume >10 cm3 under transvaginal or abdominal ultrasound. non-obese group are the women BMI < 30 between age of 18 and 35. |
| Obese PCOS | – | Other: hepassocinObese group are the women with BMI > 30 between age of 18 and 35. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A total of 60 patients with PCOS aged between 18 and 35 and age matched 30 healthy women with BMI < 30 were enrolled to the study.
Key inclusion criteria (1 listed)
- 60 patients with PCOS aged between 18 and 35 and age-matched 30 healthy women with BMI<30
Key exclusion criteria (2 listed)
- Premature ovarian failure (FSH >30 mIU/mL), tumors secreting androgens, non-classical congenital adrenal hyperplasia, Cushing syndrome and irregular menses due to thyroid dysfunction (TSH >5 mIU/L ), hyperprolactinemia, more than twofold high transaminase levels (>70 U/L), patients with cigarette smoking, alcohol consumption, oral contraceptives use, medications that are affecting liver function test, insulin metabolism and lipid metabolism, patients with a history of chronic diseases such as diabetes mellitus, hypertension, chronic liver disease, chronic kidney disease, autoimmune disease, inflammatory disease, malignant disease, bleeding disorders, and thrombosis were also excluded. All the patients were beta-HCG, hepatitis B surface antigen, and hepatitis C antibody negative.
- -
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 |
|---|---|---|
| hepassocinhepassocin levels in polycystic ovary syndrome | Other | Control group, Non-obese PCOS, Obese PCOS |
Primary outcome
Hepassocin levels in patients with polycystic ovary syndrome
Time frame: January 2020-March 2020
hepassocin levels should be increased in polycyctic ovary syndrome due to its relation with insulin resistance.
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 30 Apr 2020.
- Individual participant dataSharing planned: Undecided
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.
fatma ketenci gencer study director
Gaziosmanpasa Taksim Education and Research Hospital
sibel bektas study chair
Gaziosmanpasa Taksim Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepassocin (Hepatocyte-derived Fibrinogen-related Protein 1) and Polycystic Ovary Syndrome, run by Fatma ketenci gencer at 1 site in Turkey (Türkiye).
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 2 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 30 Apr 2020. 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 Turkey (Türkiye). 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?
Hepassocin levels in patients with polycystic ovary syndrome (time frame: January 2020-March 2020). 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 30 Apr 2020.