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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04448730
Other study ID # EZTB24
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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