Polycystic OvaryNCT04448730
Polycystic Ovary Syndrome and BETATROPHIN
An observational study of Polycystic Ovary and Obesity, run by Hatice Akkaya at 1 site in Turkey (Türkiye).
Trial summary
This is an original study giving an information about the association body mass index, polycystic ovary syndrome and betatrophin. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary, Obesity
- What is being tested?
- serum marker levels
- How many people
- 73 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 30 Dec 2019
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Comparison of the Betatrohin serum marker of insulin resistance in normal weight and overweight women with polycystic ovary syndrome cases.
Who may be able to join
- -Polycystic ovary syndrome according to 2003 Rotterdam PCOS Consensus diagnostic criteria
Who cannot join
- pregnancy,
- an additional systemic disease (i.e.,hyperprolactinemia, thyroid dysfunction, liver or kidney diseases, cardiovascular disease, hyperlipidemia, type 1 or type 2 diabetes, chronic or acute infection within the previous 30 days),
- morbid obesity,
- smoking,
- the use of medications for contraception, androgen excess, hypertension, hyperglycemia or dyslipidemia at least 3 months before the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can the Betatrophin be a Reliable Marker of Insulin Resistance in Normal Weight and Overweight Women With Polycystic Ovary Syndrome?
This is an original study giving an information about the association body mass index, polycystic ovary syndrome and betatrophin.
Read the detailed description
Introduction: Betatrophin is a protein hormone which has a significant role in glucose homeostasis and lipid metabolism. The aim of this study is to compare the levels of serum betatrophin in overweight and normal weight women with PCOS.
Material and Method: Thirty-five patients normal weight women with PCOS (BMI<25) and 38 obese women with PCOS (BMI≥25) were included in this prospective, cross-sectional study. Patients were selected according to Rotterdam criteria. Serum betatrophin levels were studied by ELISA method and then compared between these two groups besides the following additional parameters as waist circumference/hip circumference ratio, fasting blood glucose, 75 g OGTT (oral glucose tolerance test) results and HOMA-IR levels.
- Conditions
- Polycystic Ovary, Obesity
- Being tested
- serum marker levels
- Keywords
- Betatrophin, PCOS, obesity, insulin resistance
- 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.
serum marker levelsDiagnostic test
two groups comparisons
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (normal weight with PCOS ) | 35 cases Receives: Diagnostic Test: serum marker levels | |
| overweight PCOS | 38 cases Receives: Diagnostic Test: serum marker levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum Betatrophin levels
ng/L
Measured: 30 min
Secondary outcomes (3)
Waist/hip ratio
centimeter
Measured: 5 min
75 gr OGTT(oral glucose tolerance test)
(mg/dl)
Measured: 2 hours
BMI (body mass index)
kg/m2
Measured: 5 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2020
- Study start1 Jan 2018
- Primary completion30 Jul 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic OvaryStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hatice Akkaya
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Hatice Akkaya, Kayseri Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448730
- Sponsor's protocol ID
- EZTB24
- Status last verified
- Jan 2019
- First submitted
- 23 Jun 2020
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If needed
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Betatrophin be a Reliable Marker of Insulin Resistance in Normal Weight and Overweight Women With Polycystic Ovary Syndrome?
- ClinicalTrials.gov ID
- NCT04448730
- Acronym / sponsor ID
- EZTB24
- Conditions
- Polycystic Ovary, Obesity
- Keywords
- Betatrophin, PCOS, obesity, insulin resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Hatice AkkayaOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 26 Jun 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.
This is an original study giving an information about the association body mass index, polycystic ovary syndrome and betatrophin.
Detailed description
Introduction: Betatrophin is a protein hormone which has a significant role in glucose homeostasis and lipid metabolism. The aim of this study is to compare the levels of serum betatrophin in overweight and normal weight women with PCOS.
Material and Method: Thirty-five patients normal weight women with PCOS (BMI<25) and 38 obese women with PCOS (BMI≥25) were included in this prospective, cross-sectional study. Patients were selected according to Rotterdam criteria. Serum betatrophin levels were studied by ELISA method and then compared between these two groups besides the following additional parameters as waist circumference/hip circumference ratio, fasting blood glucose, 75 g OGTT (oral glucose tolerance test) results and HOMA-IR levels.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (normal weight with PCOS ) | – | Diagnostic Test: serum marker levels35 cases |
| overweight PCOS | – | Diagnostic Test: serum marker levels38 cases |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Comparison of the Betatrohin serum marker of insulin resistance in normal weight and overweight women with polycystic ovary syndrome cases.
Key inclusion criteria (1 listed)
- -Polycystic ovary syndrome according to 2003 Rotterdam PCOS Consensus diagnostic criteria
Key exclusion criteria (5 listed)
- pregnancy,
- an additional systemic disease (i.e.,hyperprolactinemia, thyroid dysfunction, liver or kidney diseases, cardiovascular disease, hyperlipidemia, type 1 or type 2 diabetes, chronic or acute infection within the previous 30 days),
- morbid obesity,
- smoking,
- the use of medications for contraception, androgen excess, hypertension, hyperglycemia or dyslipidemia at least 3 months before the study.
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 |
|---|---|---|
| serum marker levelstwo groups comparisons | Diagnostic test | Group 1 (normal weight with PCOS ), overweight PCOS |
Primary outcome
serum Betatrophin levels
Time frame: 30 min
ng/L
3 secondary outcomes
Waist/hip ratio
Time frame: 5 min
75 gr OGTT(oral glucose tolerance test)
Time frame: 2 hours
BMI (body mass index)
Time frame: 5 minute
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 26 Jun 2020.
- Individual participant dataSharing planned: Yes. If needed
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Polycystic Ovary and Obesity, run by Hatice Akkaya 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 5 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 26 Jun 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?
serum Betatrophin levels (time frame: 30 min). 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 26 Jun 2020.