Polycystic Ovary SyndromeNCT03587415
Serum Preptin and Amylin Levels in Polycystic Ovary Syndrome Patients
An observational study of Polycystic Ovary Syndrome, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Preptin and amylin are pancreatic hormones which participate in glucose homeostasis. This study aims to evaluate how serum preptin and amylin levels are altered in polycystic ovary syndrome (PCOS) patients and healthy women based on BMI groups . Read more about this study
- Who is it for?
- Ages 17 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- preptin and amylin level
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Jun 2017to 7 Dec 2017
- 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 17 to 35 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Polycystic ovary syndrome
Who may be able to join
- the patients with PCOS
Who cannot join
- Cushing's syndrome 21-hydroxylase deficiency Congenital adrenal hyperplasia Thyroid dysfunction Hyperprolactinemia Diabetes Chronic cardiovascular Hepatic, renal, and hematologic diseases Malignancies Using oral contraceptives, anti-androgens, glucocorticoids, anti-hypertensives, anti-diabetics, calcium supplements and anti-obesity drugs and those who smoke or consume alcohol
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serum Preptin and Amylin Levels With Respect to Body Mass Index in Polycystic Ovary
Preptin and amylin are pancreatic hormones which participate in glucose homeostasis. This study aims to evaluate how serum preptin and amylin levels are altered in polycystic ovary syndrome (PCOS) patients and healthy women based on BMI groups .
Read the detailed description
Materials and Methods: This is a cross-sectional review of 40 PCOS patients and 40 healthy women who were matched with respect to BMI (<25 kg/m2 and ≥25 kg/m2).
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- preptin and amylin level
- Keywords
- amylin; obesity; polycystic ovarian syndrome; preptin
- Medical subject headings
- Polycystic Ovary Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preptin and amylin levelDiagnostic test
we will take both of group blood samples to compare them serum preptin and amylin
| Study group | Role | What they receive |
|---|---|---|
| Polycyctic ovary sendrome (PCOS) | these women who have PCOS, we will use their blood samples Receives: Diagnostic Test: preptin and amylin level | |
| Healty groups | These women who have reguler menstrual cycle, no akne or hirsutism, we will use their boold samples Receives: Diagnostic Test: preptin and amylin level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Preptin and Amylin Levels with Respect to Body Mass Index in Polycystic Ovary Syndrome Patients
Serum Preptin and Amylin Levels will compare between groups
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start28 Jun 2017
- Primary completion30 Nov 2017
- Study completion7 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Senol Senturk, Recep Tayyip Erdogan University Training and Research Hospital
- Investigators
- Senol sentürk, PhD, Study director, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03587415
- Sponsor's protocol ID
- 107
- Status last verified
- Jul 2018
- First submitted
- 12 Jun 2018
- Last updated
- 16 Jul 2018
- 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 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Preptin and Amylin Levels With Respect to Body Mass Index in Polycystic Ovary
- ClinicalTrials.gov ID
- NCT03587415
- Acronym / sponsor ID
- 107
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- amylin; obesity; polycystic ovarian syndrome; preptin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 28 Jun 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 7 Dec 2017 (actual)
- First posted
- 16 Jul 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.
Preptin and amylin are pancreatic hormones which participate in glucose homeostasis. This study aims to evaluate how serum preptin and amylin levels are altered in polycystic ovary syndrome (PCOS) patients and healthy women based on BMI groups .
Detailed description
Materials and Methods: This is a cross-sectional review of 40 PCOS patients and 40 healthy women who were matched with respect to BMI (<25 kg/m2 and ≥25 kg/m2).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polycyctic ovary sendrome (PCOS) | – | Diagnostic Test: preptin and amylin levelthese women who have PCOS, we will use their blood samples |
| Healty groups | – | Diagnostic Test: preptin and amylin levelThese women who have reguler menstrual cycle, no akne or hirsutism, we will use their boold samples |
Who may qualify
- Ages
- 17 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Polycystic ovary syndrome
Key inclusion criteria (1 listed)
- the patients with PCOS
Key exclusion criteria (2 listed)
- Cushing's syndrome 21-hydroxylase deficiency Congenital adrenal hyperplasia Thyroid dysfunction Hyperprolactinemia Diabetes Chronic cardiovascular Hepatic, renal, and hematologic diseases Malignancies Using oral contraceptives, anti-androgens, glucocorticoids, anti-hypertensives, anti-diabetics, calcium supplements and anti-obesity drugs and those who smoke or consume alcohol
- -
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 |
|---|---|---|
| preptin and amylin levelwe will take both of group blood samples to compare them serum preptin and amylin | Diagnostic test | Healty groups, Polycyctic ovary sendrome (PCOS) |
Primary outcome
Serum Preptin and Amylin Levels with Respect to Body Mass Index in Polycystic Ovary Syndrome Patients
Time frame: six months
Serum Preptin and Amylin Levels will compare between groups
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 16 Jul 2018.
Related trials for Polycystic Ovary Syndrome
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)
Active, not recruiting
Mindfulness-Based Education For Women With Polycystic Ovary Syndrome
Polycystic Ovary Syndrome (PCOS), Menstrual Symptoms
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
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.
Senol sentürk, PhD study director
Recep Tayyip Erdogan University
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 Syndrome, run by Recep Tayyip Erdogan University Training and Research Hospital 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 16 Jul 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 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 Preptin and Amylin Levels with Respect to Body Mass Index in Polycystic Ovary Syndrome Patients (time frame: six months). 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 16 Jul 2018; AzTrials last refreshed its copy on 8 Nov 2026.