Trial Outcomes & Findings for Comparison of Serum C Type Natriuretic Peptide Levels Between Polycystic Ovary Syndrome Patients and Healthy Women (NCT NCT04006171)

NCT ID: NCT04006171

Last Updated: 2021-11-05

Results Overview

The comparison of serum levels of C type natriuretic peptide among PCOS and healthy women

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 90 participants
• Primary outcome timeframe: Second or Third Day of Menstruation
• Results posted on: 2021-11-05

Participant Flow

The patients were recruited from Near East University Hospital, Department of Obstetrics and Gynecology.

For the last 6 months, patients with drug use that may affect menstruation like oral contraceptives, patients with cardiac or renal disease and therefore drug use, patients with hypertension hystory, history of ovarian surgery, current pregnancy, hyperprolactinemia, thyroid disease, congenital adrenal hyperplasia.

Participant milestones

Measure	Women With Polycystic Ovary Syndrome 36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	Healthy Women of Reproductive Age 30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women
Overall Study STARTED	48	42
Overall Study COMPLETED	36	30
Overall Study NOT COMPLETED	12	12

Reasons for withdrawal

Measure	Women With Polycystic Ovary Syndrome 36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	Healthy Women of Reproductive Age 30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women
Overall Study Withdrawal by Subject	8	7
Overall Study missing serum samples	2	2
Overall Study insufficient sample volume	2	3

Baseline Characteristics

Comparison of Serum C Type Natriuretic Peptide Levels Between Polycystic Ovary Syndrome Patients and Healthy Women

Baseline characteristics by cohort

Measure	Women With Polycystic Ovary Syndrome n=36 Participants 36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	Healthy Women of Reproductive Age n=30 Participants 30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	Total n=66 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants	30 Participants n=7 Participants	66 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	22 years n=5 Participants	24 years n=7 Participants	23 years n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	30 Participants n=7 Participants	66 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Cypriot	36 Participants n=5 Participants	30 Participants n=7 Participants	66 Participants n=5 Participants
Region of Enrollment Cyprus	36 participants n=5 Participants	30 participants n=7 Participants	66 participants n=5 Participants
Body Mass Index	23.20 kg/m^2 STANDARD_DEVIATION 4.26 • n=5 Participants	21.17 kg/m^2 STANDARD_DEVIATION 1.88 • n=7 Participants	22.28 kg/m^2 STANDARD_DEVIATION 3.52 • n=5 Participants

PRIMARY outcome

Timeframe: Second or Third Day of Menstruation

The comparison of serum levels of C type natriuretic peptide among PCOS and healthy women

Outcome measures

Measure	Women With Polycystic Ovary Syndrome n=36 Participants 36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	Healthy Women of Reproductive Age n=30 Participants 30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women
Serum CNP Levels of PCOS and Healthy Participants	110 pg/ml Interval 90.9 to 182.0	57 pg/ml Interval 43.3 to 151.3

PRIMARY outcome

Timeframe: Second or Third Day of Menstruation

We made a cut off value estimation for the diagnosis of PCOS by serum CNP levels using Receiver operator characteristics. The ROC curve incorporates both sensitivity (true positive rate) and specificity (true negative rate) providing a single assessment incorporating both measures. The higher the total area under the curve, the greater the predictive power of the CNP for diagnosing PCOS

Outcome measures

Measure	Women With Polycystic Ovary Syndrome n=66 Participants 36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	Healthy Women of Reproductive Age 30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women
Roc Curve of CNP	0.706 probability Interval 0.574 to 0.838	—

SECONDARY outcome

Timeframe: Second or Third Day of Menstruation

Population: FSH and LH should be evaluated during menstruation time period ( day 3)

Serum FSH and LH of PCOS and healthy women were compared

Outcome measures

Measure	Women With Polycystic Ovary Syndrome n=36 Participants 36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	Healthy Women of Reproductive Age n=30 Participants 30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women
Comparison of FSH and LH of PCOS and Healthy Women Follicle Stimulating Hormone	4.7 mIU/mL Interval 3.95 to 5.7	4.97 mIU/mL Interval 4.55 to 6.06
Comparison of FSH and LH of PCOS and Healthy Women Luteinizing Hormone	4.23 mIU/mL Interval 3.21 to 6.34	5.36 mIU/mL Interval 3.0 to 6.89

SECONDARY outcome

Timeframe: Second or Third Day of Menstruation

Serum Estradiol levels of PCOS and Healthy Women were compared

Outcome measures

Measure	Women With Polycystic Ovary Syndrome n=36 Participants 36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	Healthy Women of Reproductive Age n=30 Participants 30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women
Serum Estradiol Levels of PCOS and Healthy Women	31 pg/mL Interval 23.5 to 45.0	36.5 pg/mL Interval 25.0 to 47.3

SECONDARY outcome

Timeframe: Second or Third Day of Menstruation

serum tiroid stimulating hormone of PCOS and healthy women were compared

Outcome measures

Measure	Women With Polycystic Ovary Syndrome n=36 Participants 36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	Healthy Women of Reproductive Age n=30 Participants 30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women
Serum Tiroid Stimulating Hormone of PCOS and Healthy Women	1.61 mIU/L Interval 1.14 to 2.15	1.47 mIU/L Interval 1.28 to 1.94

SECONDARY outcome

Timeframe: Second or Third Day of Menstruation

serum prolactin levels of PCOS and healthy women were compared

Outcome measures

Measure	Women With Polycystic Ovary Syndrome n=36 Participants 36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	Healthy Women of Reproductive Age n=30 Participants 30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women
Serum Prolactin Levels of PCOS and Healthy Women	17.21 ng/mL Standard Deviation 6.65	16.80 ng/mL Standard Deviation 6.26

SECONDARY outcome

Timeframe: Second or Third Day of Menstruation

Serum Androstenedione Levels of PCOS and Healthy Women were compared

Outcome measures

Measure	Women With Polycystic Ovary Syndrome n=36 Participants 36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	Healthy Women of Reproductive Age n=30 Participants 30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women
Serum Androstenedione Levels of PCOS and Healthy Women	148.89 ng/dL Standard Deviation 52.38	84.66 ng/dL Standard Deviation 11.56

SECONDARY outcome

Timeframe: Second or Third Day of Menstruation

Serum dehydroepiandrosterone sulfate (DHEAS) Levels of PCOS and Healthy Women were compared

Outcome measures

Measure	Women With Polycystic Ovary Syndrome n=36 Participants 36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	Healthy Women of Reproductive Age n=30 Participants 30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women
Serum Dehydroepiandrosterone Sulfate (DHEAS) Levels of PCOS and Healthy Women	304.55 µg/dL Interval 224.85 to 411.2	299.95 µg/dL Interval 213.8 to 356.3

SECONDARY outcome

Timeframe: Second or Third Day of Menstruation

Serum Total Testosterone Levels of PCOS and Healthy Women were compared

Outcome measures

Measure	Women With Polycystic Ovary Syndrome n=36 Participants 36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	Healthy Women of Reproductive Age n=30 Participants 30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women
Serum Total Testosterone Levels of PCOS and Healthy Women	1.38 nmol/L Standard Deviation 0.48	0.92 nmol/L Standard Deviation 0.36

SECONDARY outcome

Timeframe: Second or Third Day of Menstruation

Serum Free Testosterone Levels of PCOS and Healthy Women were compared

Outcome measures

Measure	Women With Polycystic Ovary Syndrome n=36 Participants 36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	Healthy Women of Reproductive Age n=30 Participants 30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women
Serum Free Testosterone Levels of PCOS and Healthy Women	1.71 pg/mL Standard Deviation 0.64	1.12 pg/mL Standard Deviation 0.30

SECONDARY outcome

Timeframe: Second or Third Day of Menstruation

Serum Sex Hormone Binding Globulin Levels of PCOS and Healthy Women were compared

Outcome measures

Measure	Women With Polycystic Ovary Syndrome n=36 Participants 36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	Healthy Women of Reproductive Age n=30 Participants 30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women
Serum Sex Hormone Binding Globulin Levels of PCOS and Healthy Women	30.4 nmol/L Interval 26.8 to 53.8	59.4 nmol/L Interval 46.6 to 78.1

SECONDARY outcome

Timeframe: Second or Third Day of Menstruation

Free androgen index of participants were compared. It was calculated with the formula 100XTotal testosterone/Sex hormone binding globulin

Outcome measures

Measure	Women With Polycystic Ovary Syndrome n=36 Participants 36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	Healthy Women of Reproductive Age n=30 Participants 30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women
Free Androgen Index of Participants	4.39 % of T testosterone per SHBG Standard Deviation 2.58	1.55 % of T testosterone per SHBG Standard Deviation 0.89

SECONDARY outcome

Timeframe: Second or third day of menstruation and morning fasting

Serum glucose, total cholesterol and triglycerides levels of participants were compared

Outcome measures

Measure	Women With Polycystic Ovary Syndrome n=36 Participants 36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	Healthy Women of Reproductive Age n=30 Participants 30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women
Serum Glucose, Total Cholesterol and Triglycerides Levels of Participants Total cholesterol	164 mg/dL Interval 154.3 to 185.0	171 mg/dL Interval 146.0 to 189.0
Serum Glucose, Total Cholesterol and Triglycerides Levels of Participants triglycerides	78 mg/dL Interval 63.8 to 107.8	77 mg/dL Interval 60.0 to 90.0
Serum Glucose, Total Cholesterol and Triglycerides Levels of Participants Glucose	88.5 mg/dL Interval 83.3 to 97.8	89 mg/dL Interval 82.3 to 94.3

SECONDARY outcome

Timeframe: Second or Third Day of Menstruation-morning fasting

High density lipoprotein and low density lipoprotein levels of participants were compared

Outcome measures

Measure	Women With Polycystic Ovary Syndrome n=36 Participants 36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	Healthy Women of Reproductive Age n=30 Participants 30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women
High Density Lipoprotein and Low Density Lipoprotein Levels of Participants High density lipoprotein	53.82 mg/dL Standard Deviation 11.06	62.15 mg/dL Standard Deviation 19.48
High Density Lipoprotein and Low Density Lipoprotein Levels of Participants Low density lipoprotein	98.50 mg/dL Standard Deviation 23.61	92.92 mg/dL Standard Deviation 23.56

SECONDARY outcome

Timeframe: Second or Third Day of Menstruation-morning fasting

Serum Insulin Levels of Participants were compared

Outcome measures

Measure	Women With Polycystic Ovary Syndrome n=36 Participants 36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	Healthy Women of Reproductive Age n=30 Participants 30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women
Serum Insulin Levels of Participants	7.10 mU/L Interval 4.9 to 10.0	7.10 mU/L Interval 5.75 to 8.0

SECONDARY outcome

Timeframe: Second or Third Day of Menstruation-morning fasting

homeostatic model assessment of insulin resistance of participants were compared. The calculation was made with formula Glucose X Insulin/405.

Outcome measures

Measure	Women With Polycystic Ovary Syndrome n=36 Participants 36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	Healthy Women of Reproductive Age n=30 Participants 30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women
Homeostatic Model Assessment of Insulin Resistance of Participants	1.50 HOMA-IR Index Interval 1.05 to 2.15	1.45 HOMA-IR Index Interval 1.33 to 1.88

Adverse Events

Women With Polycystic Ovary Syndrome

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Women of Reproductive Age

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.Ali Cenk Ozay

Near East University

Phone: 00905428583248

Email: dr.alicenk@hotmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place