Polycystic Ovary Syndrome and BETATROPHIN

Completed

• Conditions: Obesity; Polycystic Ovary
• Interventions: Diagnostic Test: serum marker levels

• Registration Number: NCT04448730
• Lead Sponsor: Hatice Akkaya

Brief Summary

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 Timeline

• Study Start: 2018-01-01
• Status Verified: 2019-01
• Primary Completion: 2019-07-30
• Study Completion: 2019-12-30
• Study First Submitted: 2020-06-23
• Study First Submitted QC: 2020-06-23
• Last Update Submitted: 2020-06-23
• Study First Posted: 2020-06-26
• Last Update Posted: 2020-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 73

Inclusion Criteria

-Polycystic ovary syndrome according to 2003 Rotterdam PCOS Consensus diagnostic criteria

Exclusion criteria

• 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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1 (normal weight with PCOS )	serum marker levels	35 cases
overweight PCOS	serum marker levels	38 cases

Primary Outcome Measures

Name	Time	Method
serum Betatrophin levels	30 min	ng/L

Secondary Outcome Measures

Name	Time	Method
75 gr OGTT(oral glucose tolerance test)	2 hours	(mg/dl)
BMI (body mass index)	5 minute	kg/m2
Waist/hip ratio	5 min	centimeter

Trial Locations

Locations (1)

Kayseri Doğumevi; 🇹🇷 Kocasinan, Kayseri, Turkey