Polycystic Ovary Syndrome and BETATROPHIN

Obesity Clinical Trial

Official title:

Can the Betatrophin be a Reliable Marker of Insulin Resistance in Normal Weight and Overweight Women With Polycystic Ovary Syndrome?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04448730
• Other study ID #: EZTB24
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: January 2019
• Source: Kayseri Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an original study giving an information about the association body mass index, polycystic ovary syndrome and betatrophin.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: December 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Polycystic Ovary
• Polycystic Ovary Syndrome

Intervention

Diagnostic Test:
• serum marker levels
two groups comparisons

Locations

Country	Name	City	State
Turkey	Kayseri Dogumevi	Kocasinan	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
Hatice Akkaya

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum Betatrophin levels	ng/L	30 min
Secondary	Waist/hip ratio	centimeter	5 min
Secondary	75 gr OGTT(oral glucose tolerance test)	(mg/dl)	2 hours
Secondary	BMI (body mass index)	kg/m2	5 minute